Cognitive Recovery, Sedation, Ambulatory Gynecologic Surgery, Postoperative Recovery
Conditions
Keywords
Propofol, Ketamine, Ketofol, Sedoanalgesia, Cognitive Recovery, Ambulatory Surgery, Gynecologic Surgery, Postoperative Recovery, Mini-Mental State Examination
Brief summary
This prospective, randomized, double-blind clinical trial aims to compare the effects of three commonly used sedoanalgesia regimens on early cognitive recovery in patients undergoing ambulatory gynecologic surgery (dilatation and curettage). 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
Early postoperative cognitive recovery is an important indicator of patient safety and discharge readiness in ambulatory anesthesia. Various sedative-analgesic combinations are used for gynecologic day-case procedures; however, their effects on early cognitive recovery remain unclear. 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.
Interventions
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.
DRUGKetamine-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.
DRUGPropofol + 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.
Sponsors
Sait Fatih Öner
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Both the participants and the investigators administering sedation were blinded to the group assignments. 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.
Intervention model description
This study uses a parallel assignment model with three groups of participants. Each group receives a different sedoanalgesic regimen: propofol-fentanyl, ketamine-fentanyl, or propofol + ketamine + fentanyl (ketofol). Outcomes related to early cognitive recovery and hemodynamic stability are compared among the groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18-60 years * ASA physical status I-III * Scheduled for ambulatory dilation and curettage (D&C) under sedoanalgesia * No neurological or psychiatric disorders
Exclusion criteria
* History of neurological, psychiatric, or cognitive disorders * Inability to complete or comprehend cognitive assessment tests (MMSE) * Known drug or alcohol abuse * Pregnancy * Severe hepatic or renal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mini-Mental State Examination (MMSE) Score | Baseline and recovery (within approximately 60 minutes post-sedation) | Difference between baseline and postoperative MMSE scores measured before sedation and at recovery in the post-anesthesia care unit (PACU). The MMSE assesses early cognitive recovery after ambulatory gynecologic surgery under sedation. |
Countries
Turkey (Türkiye)
Outcome results
None listed