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Starting soon Not applicable

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

NCT07809230 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-09-14
Last updated
2026-09-09

Condition(s) studied

Colonoscopy ProceduresSedation

Investigational drug(s) / intervention(s)

Propofol groupPropofol + Ketamine

Propofol group: 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 + Ketamine: 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

Study summary

"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."

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mean Arterial Pressure — Baseline, at induction, and every 3 minutes until the end of the procedure
    Evaluation of Mean Arterial Pressure (MAP)

Trial sites (1)

FacilityCityRegionStatus
Ankara Etlik City Hospital Altındağ Ankara
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07809230 on ClinicalTrials.gov ↗ ← All trials in Turkey