NCT06358131

Propofol Versus Midazolam in Sedation for Upper and Lower Gastrointestinal Endoscopy.

Status unknown Phase 1 Last updated 10 April 2024

What this trial tests

Phase 1 trial testing Endoscopy in Gastrointestinal Diseases in 656 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
1 August 2024

1 August 2024

Quick facts

Lead sponsor	Mansoura University
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	656
Start date	1 January 2022
Primary completion	1 August 2024
Estimated completion	1 August 2024
Sites	2 locations across Egypt

Drugs / interventions tested

• Endoscopy

Conditions studied

• Gastrointestinal Diseases — all drugs for Gastrointestinal Diseases →

Sponsor

Mansoura University

Who can join

Adults 18 to 80, any sex, with Gastrointestinal Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There has been rapid growth in the number and complexity of gastrointestinal (GI) endoscopic procedures performed during the last decade. To ensure safe and effective upper GI endoscopy, the choice of an appropriate sedative agent is crucial. Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation. Benzodiazepines still the most common sedative agents used for conscious sedation, either solely or in combination with opioids for upper GI endoscopy. Propofol is a hypnotic drug used for induction of anesthesia with short half-life that permits rapid patient recovery and discharge. Thus, its use is for upper GI endoscopy was adopted in many endoscopy centers. So we are going to Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.Also we are going to Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.