Effects of Low-Dose Ketamine Added to Propofol Sedation During Colonoscopy

N/ANot Yet RecruitingNCT07809230

Ankara Etlik City Hospital100 enrolled

Overview

"This prospective observational study aims to evaluate the effects of adding low-dose ketamine (0.25 mg/kg) to standard propofol sedation on hemodynamic stability, sedation depth, and recovery times in adult patients undergoing elective colonoscopy. Sedation depth will be objectively monitored using the Bispectral Index (BIS) alongside clinical scoring. The study observes and compares two standard sedation regimens routinely used in the clinic: propofol alone versus a combination of propofol and low-dose ketamine. Researchers will record intraoperative hemodynamic parameters (mean arterial pressure, heart rate, oxygen saturation) and BIS values at regular intervals from baseline to the end of the procedure. Furthermore, postoperative recovery quality, cognitive function, and discharge readiness will be comprehensively assessed using the Modified Aldrete Score, Post Anesthetic Discharge Scoring System (PADSS), and a computerized Psychomotor Vigilance Test (PVT-B) at specific time points. The total amount of propofol consumed to maintain adequate sedation will also be compared between the two observational cohorts."

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Colonoscopy Procedures Sedation

Interventions

Propofol groupPROCEDURE

Patients in this group will receive standard propofol sedation titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy

Propofol + KetaminePROCEDURE

Patients in this group will receive a combination of standard propofol sedation and low-dose ketamine (0.25 mg/kg). Propofol will be titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled for elective colonoscopy * ASA physical status I-II Exclusion Criteria: * ASA physical status ≥ III * Allergy to propofol or ketamine * History of psychiatric illness * Advanced cardiac disease * Pregnancy * Chronic use of opioids or sedatives * Inability to cooperate * Body Mass Index (BMI) \> 35 kg/m\^2

Outcomes

Primary Outcomes

Mean Arterial Pressure

Evaluation of Mean Arterial Pressure (MAP)

Time frame: Baseline, at induction, and every 3 minutes until the end of the procedure

Secondary Outcomes

Bispectral Index (BIS) Values

Objective assessment of sedation depth using the BIS monitor

Time frame: Intraoperative (Continuous monitoring from baseline to the end of the procedure)

Total Propofol Consumption

Total amount of propofol (in mg) consumed to maintain adequate sedation (Ramsay Score 2-3)

Time frame: At the end of the procedure