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Propofol Dose-Finding for Colonoscope Insertion in Adult Patients

NCT07166640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-11-18

No results posted yet for this study

Summary

The aim of this prospective dose-finding study is to determine the ED50 of propofol required for successful colonoscope insertion in adult patients. The study is designed using Dixon's up-and-down sequential allocation method. Successful colonoscope insertion is defined as the absence of pain, movement, or vocal response, together with a MOAA/S score ≤2 at the second minute after induction, and maintained until the colonoscope passes the rectosigmoid junction. In cases of failure, an additional dose of propofol is administered, and the initial dose for the next patient is increased by 0.1 mg/kg. In cases of success, the initial dose for the next patient is decreased by 0.1 mg/kg.

The primary outcome is the determination of the ED50 of propofol for successful colonoscope insertion until passage of the rectosigmoid junction.

Conditions

  • Effect of Drug

Interventions

DRUG

Propofol

The initial dose is 1.5 mg/kg, adjusted in increments or decrements of 0.1 mg/kg according to the modified Dixon's up-and-down method. Additional rescue doses of 0.25-0.5 mg/kg is titrated if insertion is unsuccessful.

Sponsors & Collaborators

  • Kocaeli City Hospital

    lead OTHER_GOV

Principal Investigators

  • Bedirhan Günel · Kocaeli City Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-12
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07166640 on ClinicalTrials.gov