Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy

NCT06763705 | Recruiting Phase 4

• 1 other identifier: 607/45/15284
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Sedations; Conscious Sedation; Colonoscopy

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (3)

• Degree of sedation

  The degree of sedation shows the depth of sedation. It will be measured by the Observer's assessment of alertness/sedation scale with a minimum and maximum value of 1 and 5 reflecting depth of sedation. Where score 1 means deeply sedated while score 5 means fully awake. Higher scores means not enough sedation.

  every 3 minutes till the end of procedure

• Onset of sedation

  Onset of sedation means how rapidly patient is sedated after giving the sedative medication. if after 20 minutes, patient not sedated then it will be considered failed to sedate.

  It will be measured every 1 minute till 20 minutes.

• Adverse events and complication

  Adverse events are any unintended or undesirable clinical occurrences that arise during or after a medical procedure, treatment, or intervention. These events may be related to the procedure itself, the medications administered. These may include hypotension, bradycardia, tachycardia, hypoxia, oversedation leading to respiratory suppression

  Monitored continuously during procedure and post procedure for 2 hours and then up to 48 hours after discharge on telephone

Secondary Outcomes (2)

• Patient's satisfaction with the procedure

  2 hours from the start of the procedure.

• procedure completion rate

  Decision for procedure completion successfully or not will be at 1 hour. Procedure completion rate at 6 months

Study Arms (3)

Midazolam + Fentanyl

EXPERIMENTAL

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

Drug: Midazolam; Drug: Fentanyl

Propofol

EXPERIMENTAL

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

Drug: Propofol

Propofol +Fentanyl

EXPERIMENTAL

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

Drug: Propofol; Drug: Fentanyl

Interventions

Midazolam DRUG

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

Midazolam + Fentanyl

Propofol DRUG

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

Propofol; Propofol +Fentanyl

Fentanyl 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.

Midazolam + Fentanyl; Propofol +Fentanyl

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qassim Health Cluster: lead

Study Sites (1)

King Saud Hospital

Unaizah, Al-Qassim Region, 56437, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Midazolam; Propofol; Fentanyl

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Mohammed S Alsulaimi, consultant gastroenterologist

CONTACT

+966 551132380; Dr.abosaud@windowslive.com

Muhammad Y Memon, FCPS,MRCP

CONTACT

966 570357122; memon.dryousuf@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant gastroenterology

Model Details: a randomized, double-blinded study 3 arms study

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 8, 2025
• Study Start: June 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)