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

ConditionsColonoscopy ProceduresSedation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara Etlik City Hospital

About this trial

"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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective colonoscopy

ASA physical status I-II

Disqualifiers

ASA physical status ≥ III

Allergy to propofol or ketamine

History of psychiatric illness

Advanced cardiac disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Propofol group

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Propofol GroupActive comparator 1 intervention
Group B: Propofol + Ketamine GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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)
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara Etlik City Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: