Research ArticleClinical Studies
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Propofol Versus Dexmedetomidine for Conscious Sedation During Vaginal Hysterectomy With Pre-emptive Local Anesthesia: A Prospective Cohort Study

SOFIA HADZILIA, THEMOS GRIGORIADIS, ANASTASIA PRODROMIDOU, EMMANOUIL STAMATAKIS, DIMITRA PAPADOPOULOU, DIMITRIOS ZACHARAKIS, STAVROS ATHANASIOU and DIMITRIOS VALSAMIDIS
In Vivo September 2024, 38 (5) 2425-2433; DOI: https://doi.org/10.21873/invivo.13711

Abstract

Background/Aim: Hysterectomy is the most frequent gynecological surgery. Vaginal hysterectomy (VH) seems to be related to favorable perioperative outcomes compared to abdominal or laparoscopic approaches. As the population ages, anesthesia that is safer for the elderly, such as local anesthesia (LA) with conscious sedation, is gaining popularity and is related to favorable outcomes in patients’ recovery compared to general or regional anesthesia. We aimed to evaluate the efficacy of dexmedetomidine versus propofol for women undergoing VH for uterine prolapse under LA and conscious sedation. Patients and Methods: A prospective study on 40 women with uterine prolapse stage ≥3 who had VH under LA with conscious sedation under either dexmedetomidine (n=20) or propofol (n=20) was performed. A standardized surgical approach with continuous hemodynamic monitoring and sedation assessment using the Ramsay Sedation Scale (RSS) was conducted. The primary endpoint of the study was to determine the percentage of patients receiving intraoperative fentanyl. Results: Analysis of outcomes demonstrated a significant reduction in the proportion of patients requiring intraoperative rescue fentanyl (35% vs. 5%, respectively, p=0.04) and in postoperative pain scores, with more patients achieving an optimal RSS score of 3 in the dexmedetomidine group. Conclusion: Based on the findings of the present study, dexmedetomidine offered superior analgesia and patient comfort compared to propofol, suggesting a favorable anesthetic profile for VH under LA.

Key Words:

Hysterectomy is the most common gynecological surgical procedure worldwide and its prevalence varies significantly across different regions. In particular, the incidence of hysterectomies in the USA and Australia is double compared to Scandinavian countries (1, 2). According to the American College of Obstetricians and Gynecologists, vaginal hysterectomy (VH) is preferable whenever feasible, especially for benign cases, as it is associated with reduced surgical morbidity compared to other approaches (3). Furthermore, according to a Cochrane systematic review and metanalysis, women return to normal activities much sooner following a vaginal compared to an abdominal or laparoscopic hysterectomy (4). Favorable outcomes were also observed in the incidence of postoperative complications, including wound and urinary tract infections and fever (4).

In current practice, most vaginal procedures are performed under general (GA) or regional anesthesia (RA). However, the increasingly aging population has led to the need for the development of anesthetic methods associated with fewer intra-operative and Postoperative complications. The elderly population comprises individuals above the age of 65 years who are often affected by other severe co-morbidities (5). A large systematic review comparing the effects of GA and RA on outcomes of elderly patients after hip surgery found that both were associated to the same extent with multiple Postoperative complications, such as sepsis, acute kidney failure, and myocardial infraction (6). Nevertheless, compared to RA, GA was associated with a higher degree of secondary complications, such as cerebral hemorrhage, pulmonary embolism, prolonged Intensive Care Unit stay, and delirium (6). One of the main concerns is Postoperative cognitive dysfunction (POCD), which has been primarily associated with major surgeries in this population. Over the years, numerous studies have explored the incidence of POCD, yielding conflicting results. Although earlier studies (7) found an increased incidence of postoperative delirium in patients who received GA, more recent studies (8, 9) observed no difference in the incidence of POCD between patients receiving GA and those receiving RA.

The rising concept of Enhanced Recovery After Surgery protocols, aiming for a rapid recovery and mobilization of surgical patients, has expanded the research on the field of minimally invasive anesthesia (10). The use of local anesthesia (LA) for VH has been associated with favorable outcomes on patient recovery (11-13). In addition to this, simultaneous conscious sedation maintains patients’ airway reflexes and response capability while suppressing fear and anxiety of surgery (14). The potential advantages of LA with sedation include a shorter recovery period, less Postoperative nausea and vomiting, and the absence of throat soreness and urinary retention (12).

The objective of the present study was to assess the most effective regimen between dexmedetomidine and propofol for conscious sedation in patients undergoing VH performed under LA.

Patients and Methods

This was a prospective crossover study on women who underwent VH combined with anterior and posterior colporrhaphy for the management of symptomatic uterovaginal prolapse. The local Ethics Committee approved the clinical protocol in adherence with the Declaration of Helsinki (550/29-09-2022) and all patients signed an informed consent form.

The inclusion criteria comprised women with uterine prolapse stage ≥3 according to the Pelvic Organ Prolapse quantification system (15), aged 55 to 80 years, with American Society of Anesthesiologists grade II-III. The exclusion criteria included age <18 years; medical history of psychiatric disease, diabetes mellitus, alcohol or drug abuse; allergy to lidocaine, ropivacaine or opioids; and current use of opioids or glucocorticoids.

During the pre-operative visit, informed consent was obtained, and patients were counseled concerning the available anesthetic options. Counselling involved a discussion of the potential advantages of LA with sedation. The final decision on the anesthetic method was made by each patient.

Study protocol. All cases were seen at a tertiary referral urogynecology unit by the same team of surgeons with experience performing transvaginal surgery under LA. Patients were positioned in the lithotomy position using Allen stirrups for support of the lower extremities. Antibiotic prophylaxis with cefazolin commenced within 60 min prior to the beginning of the operation. Sedation in both groups was established before the first injection of LA by the surgeon. Patients were consecutively assigned to receive either dexmedetomidine (n=20) or propofol (n=20) intravenously (i.v.) for conscious sedation. All patients were pre-medicated with 40 mg i.v. omeprazole and 0.02 mg/kg midazolam i.v. Standard intraoperative monitoring was performed, including electrocardiography, non-invasive blood pressure, heart rate (HR), respiratory rate, arterial oxygen saturation (SaO2) and capnography. Oxygen was administered through a Venturi face mask. The sedation level was assessed every 1 to 5 min for the first 10 min and thereafter intraoperatively at specific procedural stages using the Ramsay Sedation Scale (RSS) (16). According to this scale, the patient’s sedation level was scored from 1 to 6, with score 1 representing an anxious and agitated or restless patient and score 6 indicating a patient with no response.

Patients in the dexmedetomidine group were infused a bolus dose of 1 μg/kg dexmedetomidine for 10 min once they entered the operating theater, followed by an infusion of 0.7-1 μg/kg/min. In the propofol group, a bolus dose of 0.5 mg/kg was administered once the surgeons were ready to begin and then a dose of 0.25 mg/kg every 60 seconds until sedated, followed by an infusion of 10-15 μg/kg/min with increments of 5 μg/kg/min every 5 min in cases of inadequate sedation. The target sedation level was an RSS of at least 2, with the desirable RSS being 3. In cases of pain, 0.25 μg/kg fentanyl was administered as rescue analgesia. The total amount of intraoperative fentanyl administered was recorded.

Concerning LA, 2% lidocaine with epinephrine in a 1:200,000 ratio (40 ml) and 0.5% ropivacaine (40 ml), was injected at the surgical site. The maximum dose of LA was calculated based on the ropivacaine limiting dose (3 mg/kg). Patients received a maximum of 80 ml of LA.

The surgical technique used for VH has been previously elsewhere (11). Commencement of surgery was allowed after achieving the predefined level of sedation (RSS ≥2-3). Intra-operatively, infiltration of the LA solution was performed before each step of the VH: on the anterior and posterior cervical lip of the cervix (prior to grasping of the cervix with tenaculum forceps), prior to the circumferential incision of the cervix, and prior to the ligation of the uterosacral, cardinal and round ligaments. Following VH, two polydioxanone suture 1.0 sutures were placed at the intermediate portion of the uterosacral ligament on both sides after local infiltration with the anesthetic solution. These sutures were used for the apical suspension of the vaginal vault at the end of the procedure. Subsequently, closure of the peritoneum was performed, and LA was infiltrated into the anterior and posterior vaginal walls and perineum for pelvic floor repair, consisting of an anteroposterior colporrhaphy and perineoplasty.

Patient demographics, indication for surgery, type of surgery and baseline hemodynamic variables [systolic arterial pressure, diastolic arterial pressure, mean arterial pressure (MAP) and HR] were recorded.

The percentage of patients receiving fentanyl intra-operatively was set as the primary outcome. The secondary outcomes included RSS with the desirable score being 3, alteration of hemodynamic variables, pain at rest and during coughing, tramadol consumption, sleepiness, nausea and vomiting, hospital stay, need for conversion to GA, and postoperative complication rates. Pain was assessed using Visual Analog Scale (VAS) score at rest and during coughing at 2, 4, and 24 h postoperatively.

Statistical analysis. Quantitative variables are expressed as the mean with standard deviation or as median and interquartile range. Qualitative variables are expressed as absolute and relative frequencies. For the comparison of proportions, chi-square and Fisher’s exact tests were used. Independent samples Student’s t-tests and Mann–Whitney tests were used for the comparison of quantitative variables between the two study groups. All reported p-values are two-tailed. Statistical significance was set at p<0.05 and analyses were conducted using SPSS statistical software (version 22.0) (IBM, Armonk, NY, USA).

Results

A total of 40 patients completed the study protocol and were included in the analysis. Twenty patients received propofol while the subsequent 20 patients received dexmedetomidine. The groups had similar demographic and clinical characteristics (Table I). The mean age of the dexmedetomidine group was 69.1±6.8 years and in the propofol group it was 68.6±7.6 years (p=0.845). The majority of patients were overweight or obese in both groups (80% and 65%, respectively, p=0.532).

View this table:
Table I.

Patient demographical and clinical characteristics by group.

The overall percentage of patients that received fentanyl at at least one timepoint throughout the operation was significantly higher in the propofol group compared to the dexmedetomidine group (35% vs. 5%, p=0.04) (Table II).

View this table:
Table II.

Intra-operative fentanyl consumption.

The RSS throughout surgery was also significantly different between the two groups; the level of sedation as assessed by RSS was found to be optimal in the dexmedetomidine group compared to the propofol group. The majority of patients in the dexmedetomidine group reached the desirable RSS score of 3 compared to the patients in the propofol group (83.2% vs. 8.8%) (Figure 1). Conversely, the majority of patients in the propofol group had an RSS of 2 (91.2%). This implies that while the effect of propofol was relatively effective at the specified dosage for conscious sedation, it is not as effective as dexmedetomidine (Figure 1). Concerning deeper sedation (RSS=4), the dexmedetomidine group exhibited an incidence of 18.8%, whereas no patients recorded such scores (RSS ≥4) in the propofol group (Figure 1).

Figure 1.
Figure 1.

Ramsay Sedation Scale (RSS) scores of patients receiving propofol vs. those receiving dexmedetomidine at all operation times.

The percentage of patients with an absolute change of systolic blood pressure ≥20% from baseline did not differ between the two groups (Figure 2). However, for diastolic arterial pressure, this proportion was significantly higher in the propofol group at circumferential incision of the cervix (p=0.04) and ligation and suturing of the uterine artery (p=0.017) (Figure 3). Concerning changes of MAP, at the end of the operation, significantly more patients in the dexmedetomidine group presented a change ≥20% from baseline (p=0.03) (Figure 4). Finally, changes in HR were more prevalent in the dexmedetomidine group at 5 and 10 min of sedation, as well as at the end of the surgery (Figure 5).

Figure 2.
Figure 2.

Percentage of patients with an absolute change of systolic blood pressure ≥20% from baseline.

Figure 3.
Figure 3.

Percentage of patients with an absolute change of diastolic blood pressure ≥20% from baseline.

Figure 4.
Figure 4.

Percentage of patients with an absolute change of mean blood pressure ≥20% from baseline.

Figure 5.
Figure 5.

Percentage of patients with an absolute change of heart rate ≥20% from baseline.

The main postoperative outcomes are presented in Table III. In particular, the VAS score was higher in the propofol group 2 h after surgery both at rest (3 vs. 0, p=0.002) and during coughing (4.5 vs. 0, p<0.001) (Table III). Vomiting, nausea and sleepiness were similar in both groups. Tramadol consumption was significantly higher in the propofol group 4 h after surgery (p=0.04) (Table III).

View this table:
Table III.

Postoperative patient characteristics by group.

Discussion

The present study aimed to evaluate the impact of dexmedetomidine and propofol for conscious sedation among patients undergoing VH under LA in terms of effectiveness, analgesic effect, and security profile. We observed that significantly fewer patients needed intraoperative fentanyl as rescue analgesic in the dexmedetomidine group compared to the propofol group (5% vs. 35%). The desirable RSS score 3 was reached in significantly more patients of the dexmedetomidine group. Postoperative VAS scores both at rest and during coughing, as well as tramadol consumption, were significantly lower in the dexmedetomidine group.

The significant superiority of dexmedetomidine in reducing postoperative pain can be attributed to the potential analgesic effects of this drug that are lacking in propofol (17). In studies where dexmedetomidine was compared to placebo, pain relief was significantly greater (18). The mechanism by which dexmedetomidine exhibits analgesia is through alpha-2 adrenergic inhibition of norepinephrine release, inducing hyperpolarization and inhibition of pain signaling in the cerebral cortex (18). Additionally, the release of nitric oxide, due to the release of acetylcholine from spinal interneurons, can also contribute to its analgesic effects (18). Another studied mechanism of the analgesic effect of dexmedetomidine is the prolongation of the action of ropivacaine when dexmedetomidine is administered either i.v. or perineurally in peripheral nerve blocks (19).

The efficacy of dexmedetomidine versus propofol for conscious sedation in patients undergoing procedures under LA for various indications has been investigated by studies on other types of surgery. More specifically, our findings are compatible with those by Wang et al., who compared conscious sedation with propofol versus dexmedetomidine in patients undergoing inguinal hernia repair under LA (20). The authors found that fentanyl requirement and postoperative pain score were lower in the dexmedetomidine group (p<0.001). Additionally, time to sedation and recovery time were considerably prolonged in the dexmedetomidine group (p<0.001) (20). This was, however, not observed in the study by Srivastava et al., who compared dexmedetomidine with propofol in patients undergoing endoscopic retrograde cholangiopancreatography (p=0.288) (21). They reported a faster achievement of the desirable RSS score of 3-4 in the propofol group compared to the dexamethasone group (7 vs. 11 min), and this level of sedation was then maintained throughout the procedure (21).

In the context of outpatient colonoscopy, the study by Karanth et al. found that dexmedetomidine provides comparable efficacy to propofol for the required conscious sedation. However, systolic hypotension in the dexmedetomidine group was more prevalent, indicating the difference in the side-effect profiles of these drugs, particularly concerning blood pressure management (22). On the contrary, the randomized study by Mukherjee et al. indicated the superiority of dexmedetomidine for conscious sedation in terms of both sedation level and surgeon’s satisfaction in orbital surgeries performed under LA (23). In the study by Bingol Tariverdi et al., the two sedatives were compared for hysteroscopic procedures (24). The outcomes indicated that the group sedated with dexmedetomidine experienced reduced post-procedure discomfort and more stable sedation levels, although it necessitated closer monitoring of cardiovascular parameters. These findings highlight the potential benefits of dexmedetomidine for certain outpatient procedures.

Hemodynamic instability, particularly bradycardia, is one of the well-known effects of dexmedetomidine and is therefore contraindicated in patients with bradycardia and AV conduction block (25). The HR was lower during all the surgical steps in the dexmedetomidine group compared to the propofol group, with the greatest variation occurring during 5 and 10 min of surgery (Figure 5). Bingol Tanriverdi et al. found HR to be significantly lower in their dexmedetomidine group (24). Wang et al. l found greater reduction in HR in their dexmedetomidine group than in their propofol group (20). Nevertheless, even though the present study showed some degree of reduced HR compared to baseline, it was not clinically significant.

Infiltration of LA into the incision site before surgical incision is presumed to have superior postoperative analgesic effects due to a pre-emptive analgesia mechanism (12). The concept of pre-emptive analgesia was first introduced by Crile in 1913, describing the use of regional blocks in conjunction with GA in order to inhibit transmission of unsuppressed noxious stimuli to the central nervous system (26). According to this theory, analgesia for a surgical procedure should be administered prior to the initiation of incisional inflammatory signals to prevent central nervous system sensitization to pain (27). Human studies of patients undergoing various operations under epidural anesthesia so as to prevent transmission of afferent input of pain signals showed favorable results of the pre-emptive effect (27).

The randomized double-blind study by Athanasiou et al. evaluated the efficacy of LA infiltration with ropivacaine in reducing postoperative pain in patients undergoing VH for the management of pelvic organ prolapse (28). All their patients received anesthesia with combined spinal epidural block, with the study group also received pre-emptive analgesia with ropivacaine 0.5% in the round ligaments, uterosacral ligaments and perineal body, while a control group received infiltration with placebo solution. Pain intensity and the proportion of patients with moderate to severe pain at 2- and 4-h postoperatively during rest and coughing were both significantly lower in the ropivacane group compared to the control (p=0.007, p=0.02, p=0.009 and p=0.008, respectively) (28). Hristovska et al., randomized patients undergoing VH to a group infiltrated with 50 ml of 0.5% ropivacaine and a group infiltrated with saline (29). Pain at rest and during coughing was significantly lower in the study group at all times, while morphine consumption was higher in the control group compared to the study group (25 vs. 10 mg) (29).

Healthcare advancements have increased life expectancy, leading to an aging Western population and a simultaneous rise in urogynecological disorders among women, with an estimated prevalence of 20-25% (30). These disorders, including urinary and anal incontinence, urgency and pelvic organ prolapse, can have a significant impact on a patient’s quality of life, often requiring surgical repair. Despite the conservative therapeutic strategies that are available, the lifetime risk of surgery is as high as 20% among women (31). The choice of the type of anesthesia for these procedures is debated and should balance safety, efficacy, cost, and patients’ performance status. In selected cases, LA is an essential alternative to GA and RA, especially in patients unfit for GA or where LA might offer significant perioperative benefits.

To that end, the pilot study by Athanasiou et al. compared postoperative pain and recovery parameters in patients who had VH under combined spinal epidural block with those under LA with conscious sedation for the management of pelvic organ prolapse (32). The LA group (n=20 patients) presented significantly decreased pain scores at 2, 4 and 8 h postoperatively, while the need for opioids was also significantly reduced in the LA group (p=0.002) (32). Nevertheless, data are still limited on the use of regimens for conscious sedation under LA during VH (11, 13, 33). Based on the currently available literature, this is the first trial comparing the two agents for conscious sedation in VH under LA. We acknowledge that the choice between dexmedetomidine and propofol may depend on the specific context of the procedure, patient characteristics, and the clinical settings. Clinicians should weigh the benefits and drawbacks of each agent, including onset time, duration of action, side effects, and the potential need for additional interventions such as blood pressure support.

Our study has several limitations. Firstly, it was prospective crossover study and not a double-blinded randomized control trial, which means that selection bias could not be completely eliminated. Additionally, the time to achieve the desirable RSS score was not measured, that may potentially lead to lack of evidence concerning the time needed by each agent to reach the desirable effect. Finally, there was a lack of depth of anesthesia monitoring, therefore oversedation and undersedation could not be quantified.

Conclusion

The use of dexmedetomidine for conscious sedation was found to have a superior analgesic efficacy compared to propofol in patients undergoing VH under LA for pelvic organ prolapse. Additionally, it was more effective in consciously sedating patients, since most patients had optimal RSS scores throughout the operation in the dexmedetomidine group. The selection of dexmedetomidine or propofol for sedation should be tailored to the procedure specifics, patient profile, and clinical environment, considering each drug’s onset, duration, side-effects, and any additional interventions required. Further well-designed randomized trials are warranted to validate the potential superiority of dexmedetomidine in achieving optimal conscious sedation for the performance of VH under LA.

Footnotes

  • Authors’ Contributions

    Conceptualization: S.H., S.A. and D.V.; methodology: S.H, and T.G.; software: S.H, D. P.; validation: S.H., D.P., and A.P.; formal analysis: S.H, D. P. and A.P.; investigation: S.H, D. P., E.S. and T.G.; resources: S.H and D.P.; data curation: D.P., E.S. and D.Z; writing – original draft preparation, S.H, T,G, D.P, A.P. and D.Z.; writing – review and editing: S.H, S.A, T.G and D.V.; visualization: S.A, T.G. and D.V.; supervision: S.A and D.V; project administration: S.H and S.A. All Authors have read and agreed to the published version of the article.

  • Conflicts of Interest

    The Authors declare no conflicts of interest.

  • Funding

    This research received no external funding

  • Received April 19, 2024.
  • Revision received June 25, 2024.
  • Accepted June 26, 2024.

This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY-NC-ND) 4.0 international license (https://creativecommons.org/licenses/by-nc-nd/4.0).

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Propofol Versus Dexmedetomidine for Conscious Sedation During Vaginal Hysterectomy With Pre-emptive Local Anesthesia: A Prospective Cohort Study
SOFIA HADZILIA, THEMOS GRIGORIADIS, ANASTASIA PRODROMIDOU, EMMANOUIL STAMATAKIS, DIMITRA PAPADOPOULOU, DIMITRIOS ZACHARAKIS, STAVROS ATHANASIOU, DIMITRIOS VALSAMIDIS
In Vivo Sep 2024, 38 (5) 2425-2433; DOI: 10.21873/invivo.13711
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