University of Health Sciences Kocaeli City Hospital
Kocaeli, Izmit, 41100, Turkey (Türkiye)
NCT Number: NCT07166640
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Kocaeli, Izmit, 41100, Turkey (Türkiye)
The procedure is performed by an experienced endoscopist. If, during passage of the colonoscope through the rectosigmoid junction, the patient moves, experiences pain, vocalizes, or if the MOAA/S score is ≥3 at the second minute after induction, the insertion is defined as unsuccessful, and an additional rescue dose of 0.25-0.5 mg/kg propofol is titrated intravenously. The initial propofol dose for the next patient is then increased by 0.1 mg/kg.
If there is no movement during passage of the rectosigmoid junction, the patient reports no pain, and the MOAA/S score is ≤2 at the second minute after induction, the insertion is defined as successful, and the initial dose for the next patient is decreased by 0.1 mg/kg.
The conditions for colonoscope insertion are evaluated only at the initial attempt. If, after the start of the procedure, the patient experiences pain, moves, vocalizes, or the MOAA/S score is ≥3, an additional dose of 0.25-0.5 mg/kg propofol is titrated as required.
Throughout the procedure, the target is to maintain a MOAA/S score ≤2, which is systematically assessed at 2-minute intervals. Vital signs, procedure duration, and drug dosages are recorded for all patients.
At the end of the procedure, patients are awakened with verbal and tactile stimuli. After completion of colonoscopy, all patients are transferred to the post-anesthesia care unit for close monitoring until achieving a Modified Aldrete score of 10. Patients with a Modified Aldrete score of 10 are discharged.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At 2 minutes after induction (during colonoscope insertion)
The median effective dose (ED50) of propofol required for successful colonoscope insertion in geriatric patients will be determined using the modified Dixon's up-and-down method. Successful insertion is defined as the absence of movement or vocalization and a MOAA/S score ≤2 within 2 minutes after induction, maintained until the colonoscope passes the rectosigmoid junction.
Time frame: At 2 minutes after induction (during colonoscope insertion)
The median effective dose (ED95) of propofol required for successful colonoscope insertion in geriatric patients will be determined using the modified Dixon's up-and-down method. Successful insertion is defined as the absence of movement or vocalization and a MOAA/S score ≤2 within 2 minutes after induction, maintained until the colonoscope passes the rectosigmoid junction.
Time frame: The cumulative amount of rescue propofol administered during the procedure will be recorded.
After induction until the end of the colonoscopy procedure
Time frame: The cumulative amount of total propofol administered during the procedure will be recorded.
From induction until the end of the colonoscopy procedure
Time frame: Immediately after first propofol administration
Pain during propofol injection will be assessed as a binary variable (Yes/No), evaluated immediately after the first propofol injection. Presence of pain = Yes, Absence of pain = No.
Time frame: Baseline (before sedation); at colonoscope insertion (start of procedure); 2 minutes after insertion; and at the end of the procedure (completion of colonoscopy).
Hemodynamic parameters will be recorded at the specified time points to evaluate physiological stability during the procedure.
Time frame: Baseline (before sedation); at colonoscope insertion (start of procedure); 2 minutes after insertion; and at the end of the procedure (completion of colonoscopy).
Hemodynamic parameters will be recorded at the specified time points to evaluate physiological stability during the procedure.
Time frame: Baseline (before sedation); at colonoscope insertion (start of procedure); 2 minutes after insertion; and at the end of the procedure (completion of colonoscopy).
oxygen saturation parameter will be recorded at the specified time points to evaluate physiological stability during the procedure.
Time frame: Throughout the colonoscopy procedure
The incidence of airway interventions (chin lift, jaw thrust, mask ventilation) and associated procedural interruptions will be recorded.
Time frame: Throughout the colonoscopy procedure
The lowest SpO₂ value observed during the procedure will be documented.
Kocaeli City Hospital
Other Gov
Estimation of the Median Effective Dose of Propofol for Colonoscope Insertion in Adult Patients: A Prospective Dose-Finding Study
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