RecruitingPhase 4NCT06763705

Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy

Evaluation of Safety and Efficacy of Non-anesthesia Provider-administered Different Anesthetic Regimens During Colonoscopy. Asingle Center, Prospective Double Blind, Randomized Study


Sponsor

Qassim Health Cluster

Enrollment

157 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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Interventions

DRUGMidazolam

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

DRUGPropofol

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

DRUGFentanyl

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.


Locations(1)

King Saud Hospital

Unaizah, Al-Qassim Region, Saudi Arabia

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NCT06763705


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