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

NCT07809230 — Not applicable, Not yet recruiting, 100 participants, Ankara Etlik City Hospital

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

Registry	NCT07809230
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	100 (Estimated)
Sponsor	Ankara Etlik City Hospital (Other gov)
Conditions	Colonoscopy Procedures, Sedation
Interventions	Propofol group, Propofol + Ketamine (Procedure)
Dates	start 2026-09-14 (estimated), primary completion 2027-01-14 (estimated), completion 2027-02-14 (estimated), first posted 2026-09-09, last updated 2026-09-09
Locations	1 site in Turkey (Türkiye)

-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."

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+Arms and interventions

Arm	Type	Interventions	Description
Propofol Group	Active comparator	Procedure: Propofol group	Patients receiving standard propofol sedation according to routine clinical practice during elective colonoscopy
Propofol + Ketamine Group	Active comparator	Procedure: Propofol + Ketamine	Patients receiving standard propofol sedation combined with low-dose ketamine (0.25 mg/kg) according to routine clinical practice during elective colonoscopy

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

+Outcome measures

Primary outcomes

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

Secondary outcomes

Bispectral Index (BIS) Values [Intraoperative (Continuous monitoring from baseline to the end of the procedure)]: Objective assessment of sedation depth using the BIS monitor
Total Propofol Consumption [At the end of the procedure]: Total amount of propofol (in mg) consumed to maintain adequate sedation (Ramsay Score 2-3)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Ankara Etlik City Hospital	Altındağ, Ankara	Turkey (Türkiye)