Effects of Different Sedation Techniques on Early Cognitive Recovery After Ambulatory Gynecologic Surgery
NCT ID: NCT07267377
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2024-12-15
2025-09-15
Brief Summary
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The main objective of the study is to determine whether the use of propofol-fentanyl, ketamine-fentanyl, or their combination (ketofol-fentanyl) influences the recovery of cognitive functions during the early postoperative period.
The primary outcome is the change in the Mini-Mental State Examination (MMSE) score between baseline and recovery.
Secondary outcomes include awakening time, Aldrete recovery score (ARS), pain intensity using the visual analog scale (VAS) at 10 and 30 minutes, hemodynamic parameters, and adverse events.
Participants will be randomly assigned to one of three groups:
Group P: Propofol-fentanyl
Group K: Ketamine-fentanyl
Group KP: Propofol + ketamine + fentanyl
All patients will receive sedation to achieve a Ramsay Sedation Scale score of 3-4. Cognitive function will be assessed preoperatively and after recovery in the post-anesthesia care unit.
The study seeks to determine whether the combined use of ketamine and propofol provides any advantage in cognitive recovery or hemodynamic stability compared to single-agent sedation.
Detailed Description
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This prospective, randomized, double-blind clinical trial was conducted to compare the effects of three commonly used sedoanalgesia regimens - propofol-fentanyl, ketamine-fentanyl, and their combination (ketofol-fentanyl) - on postoperative cognitive function recovery after dilation and curettage (D\&C).
A total of 108 ASA physical status I-III patients aged 18-60 years were included and randomly allocated into three groups (n=36 each). Sedation was titrated to maintain a Ramsay Sedation Scale (RSS) score of 3-4. Cognitive function was assessed preoperatively and postoperatively using the Mini-Mental State Examination (MMSE).
The primary outcome was the change in MMSE score between baseline and recovery. Secondary outcomes included awakening time, Aldrete recovery score (ADS), visual analog scale (VAS) pain score at 10 and 30 minutes, hemodynamic stability, and adverse events.
The study aimed to identify the sedative regimen that optimizes cognitive recovery and minimizes side effects in ambulatory gynecologic anesthesia, contributing to safer and faster discharge decisions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Outcomes related to early cognitive recovery and hemodynamic stability are compared among the groups.
SUPPORTIVE_CARE
DOUBLE
Sedative solutions were prepared in identical syringes by an independent anesthesiologist not involved in data collection or analysis.
The assessing investigator was unaware of the sedative regimen used for each patient.
Study Groups
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Propofol-Fentanyl Group
Induction propofol 0.5 mg/kg + fentanyl 1 µg/kg; maintenance propofol 0.25 mg/kg as intermittent boluses to maintain RSS=3
Propofol-Fentanyl
Intravenous administration of propofol 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C).
This regimen represents the standard sedoanalgesia practice for gynecologic day-case procedures and serves as one of the comparison arms in the study.
Ketamine-Fentanyl Group
Induction ketamine 0.5 mg/kg + fentanyl 1 µg/kg; maintenance ketamine 0.25 mg/kg as intermittent boluses
Ketamine-Fentanyl
Intravenous administration of ketamine 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C).
This arm evaluates the effects of ketamine-based sedoanalgesia on cognitive and hemodynamic recovery compared with other regimens.
Propofol + Ketamine + Fentanyl Group (Ketofol)
Induction ketofol 0.75 mg/kg (1:1 mixture of propofol 10 mg/mL and ketamine 50 mg/mL, freshly prepared in a single syringe) + fentanyl 1 µg/kg; maintenance ketofol 0.25 mg/kg as intermittent boluses
Propofol + Ketamine + Fentanyl (Ketofol)
Intravenous co-administration of propofol 0.5 mg/kg, ketamine (0.5 mg/kg), and fentanyl (1 µg/kg) for sedation during ambulatory dilation and curettage (D\&C).
This combination (known as "Ketofol") aims to balance the sedative and hemodynamic effects of propofol and ketamine, and is compared with single-agent sedoanalgesia regimens.
Interventions
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Propofol-Fentanyl
Intravenous administration of propofol 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C).
This regimen represents the standard sedoanalgesia practice for gynecologic day-case procedures and serves as one of the comparison arms in the study.
Ketamine-Fentanyl
Intravenous administration of ketamine 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C).
This arm evaluates the effects of ketamine-based sedoanalgesia on cognitive and hemodynamic recovery compared with other regimens.
Propofol + Ketamine + Fentanyl (Ketofol)
Intravenous co-administration of propofol 0.5 mg/kg, ketamine (0.5 mg/kg), and fentanyl (1 µg/kg) for sedation during ambulatory dilation and curettage (D\&C).
This combination (known as "Ketofol") aims to balance the sedative and hemodynamic effects of propofol and ketamine, and is compared with single-agent sedoanalgesia regimens.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA physical status I-III
* Scheduled for ambulatory dilation and curettage (D\&C) under sedoanalgesia
* No neurological or psychiatric disorders
Exclusion Criteria
* Inability to complete or comprehend cognitive assessment tests (MMSE)
* Known drug or alcohol abuse
* Pregnancy
* Severe hepatic or renal dysfunction
18 Years
60 Years
FEMALE
No
Sponsors
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Sait Fatih Öner
OTHER
Responsible Party
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Sait Fatih Öner
Principal Investigator
Locations
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Fethi Sekin City Hospital
Elâzığ, Elaziğ, Turkey (Türkiye)
Countries
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Other Identifiers
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no.258551508; November 5, 2024
Identifier Type: OTHER
Identifier Source: secondary_id
no.258551508; November 5, 2024
Identifier Type: -
Identifier Source: org_study_id