Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07809230

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

"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."

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol Group

Procedure

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

Procedure

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

Primary outcomes

  1. Mean Arterial Pressure

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

    Evaluation of Mean Arterial Pressure (MAP)

Secondary outcomes

  1. Bispectral Index (BIS) Values

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

    Objective assessment of sedation depth using the BIS monitor

  2. Total Propofol Consumption

    Time frame: At the end of the procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aslı DÖNMEZ

CONTACT

[email protected]

00905322256473

Berat DAĞDELEN

CONTACT

[email protected]

00905538861406

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

The Effects of Adding Low-Dose Ketamine to Propofol Sedation on Bispectral Index Values, Hemodynamic Stability, and Recovery Time in Patients Undergoing Colonoscopy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.