Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2025-12-31

Brief Summary

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This is a randomized, double-blinded, prospective study which will be conducted at the Department of Gastroenterology, King Saud Hospital, Unaizah, Qassim, Saudi Arabia. This study aims to compare safety and efficacy of different types of sedation medications for elective colonoscopy. Colonoscopy is a procedure to examine and visualize the colon by a fiberoptic tube called colonoscope. Sedation helps one to relax to avoid feel any discomfort or pain during the procedure.

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Detailed Description

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The study will involve 157 patients who meet the inclusion criteria and are scheduled for elective colonoscopy. Sample size is calculated by ANOVA F test. Participants will be randomly assigned into three groups using computer-based randomization. Group I will receive intravenous midazolam + fentanyl, Group II will receive propofol only, and Group III will receive fentanyl + propofol. Dosages will be titrated as needed during the procedure, with sedation administered by trained nurses/doctors under the supervision of an anesthesiologist to ensure patient safety. Experienced endoscopists will perform the procedures, and all participants will undergo a pre-procedure evaluation, including medical history, physical examination, and assessment of allergies, comorbidities, and ASA classification. Data on patient demographics, procedure details, and sedative dosages will be collected, alongside monitoring of vital signs, oxygen saturation, and blood pressure before, during, and after the procedure.

The primary outcomes for the study include the degree of sedation, onset of sedation, patient satisfaction, and procedure completion rate. The degree of sedation will be assessed using the Observer's Assessment of Alertness/Sedation (OAA/S) scale, while the onset of sedation will be defined as the time it takes for the patient to show drowsiness and reduced responsiveness. Secondary outcomes include adverse events, recovery time, and endoscopist satisfaction. Adverse events, such as hypotension, tachycardia, bradycardia, and hypoxia, will be recorded using pre-defined criteria for each. Recovery will be assessed every 10 minutes post-procedure using the Aldrete score, with a score of 10 indicating full recovery, after which patients can be discharged. Both patient and endoscopist satisfaction will be measured on a scale of 0 to 5 using Likert scale. This comprehensive approach aims to determine the efficacy, safety, and patient/endoscopist experience associated with the three sedative regimens during colonoscopy

Conditions

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Deep Sedations Conscious Sedation Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a randomized, double-blinded study 3 arms study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Midazolam + Fentanyl

Midazolam AND Fentanyl Before start of colonoscopy procedure patient will be sedated with these drugs in this group. Doses: Midazolam: Initial dose 0.5-1 mg. Additional doses: 1 mg every 2-3 min depending sedation level, maximum dose: 6 mg. till completion of the colonoscopy procedure Fentanyl Initial dose: 12.5-75 μg Additional doses: 12.5-50 μg every 2-3 minutes. Maximum dose: 100 ug

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

It will not be used alone but in combination with Fentanyl in the Midazolam + Fentanyl group.

Fentanyl

Intervention Type DRUG

Fentanyl will not be used in isolation but will be used in combination with either Midazolam or Propofol in Midazolam + Fentanyl group and Propofol + Fentanyl group, respectively.

Propofol

Propofol Before start of colonoscopy procedure patient will be sedated with propofol in this group. Dose:induction dose of 20-50 mg followed by intermittent boluses of 10-20 mg according to the patient response. Maximum total dose of 200 mg. Till completion of the colonoscopy

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

It will used alone in Propofol group and in combination with Fentanyl in the Propofol + Fentanyl group.

Propofol +Fentanyl

Propofol AND Fentanyl Before start of colonoscopy procedure patient will be sedated with these drugs in this group. Doses: Propofol: Induction dose of 20-50 mg followed by intermittent boluses of 10-20 mg according to the patient response. maximum total dose of 200 mg. Till completion of the colonoscopy procedure.

Fentanyl Initial dose: 12.5-75 μg Additional doses: 12.5-50 μg every 2-3 minutes. Maximum dose: 100 ug. Till completion of the colonoscopy procedure

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

It will used alone in Propofol group and in combination with Fentanyl in the Propofol + Fentanyl group.

Fentanyl

Intervention Type DRUG

Fentanyl will not be used in isolation but will be used in combination with either Midazolam or Propofol in Midazolam + Fentanyl group and Propofol + Fentanyl group, respectively.

Interventions

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Midazolam

It will not be used alone but in combination with Fentanyl in the Midazolam + Fentanyl group.

Intervention Type DRUG

Propofol

It will used alone in Propofol group and in combination with Fentanyl in the Propofol + Fentanyl group.

Intervention Type DRUG

Fentanyl

Fentanyl will not be used in isolation but will be used in combination with either Midazolam or Propofol in Midazolam + Fentanyl group and Propofol + Fentanyl group, respectively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18-60 years
* Both Genders
* Indication of colonoscopy procedure without advanced intervention
* American Society of Anesthesiologists (ASA) physical status I or II
* Competent to give informed consent

Exclusion Criteria

* Personal history of allergic reaction or other contra-indications to midazolam, propofol or fentanyl
* Age below 18 or above 60 years
* Chronic use of benzodiazepines
* ASA physical status III or above
* Pregnancy
* History of smoking or alcohol abuse
* Body mass index \> 35 kg/m2
* History of airway obstruction or difficult intubation

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No