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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07809230

Enrollment

100

Registered

2026-09-09

Start date

2026-09-14

Completion date

2027-02-14

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy Procedures, Sedation

Keywords

colonoscopy procedures, sedation, propofol, ketamine, bispectral index

Brief 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."

Interventions

PROCEDUREPropofol 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

PROCEDUREPropofol + 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Arterial Pressure	Baseline, at induction, and every 3 minutes until the end of the procedure	Evaluation of Mean Arterial Pressure (MAP)

Secondary

Measure	Time frame	Description
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)

Countries

Turkey (Türkiye)

Contacts

CONTACTBerat DAĞDELEN

brtdagdelen@gmail.com00905538861406

CONTACTAslı DÖNMEZ

aslidonmez@hotmail.com00905322256473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026