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

Phase 1

Recruiting

• Conditions: Gastrointestinal Diseases
• Interventions: Device: Endoscopy

• Registration Number: NCT06358131
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2024-04-06
• Last Update Submitted: 2024-04-06
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 656

Inclusion Criteria

Age18 to 80 American Society of Anesthesiologists (ASA) class I-II Informed consent. Patients scheduled for upper and lower endoscopy.

Exclusion Criteria

Chronic use of drugs as benzodiazpines, neuroleptics and anticonvulsants for more than 30 days.

Hypersensitivity reactions to drugs used in the study. Psychiatric patients. Pregnancy. Being submitted to endoscopy as an emergency procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol arm	Endoscopy	-
midazolam arm	Endoscopy	-

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.	2 years	visual analog scale

Trial Locations

Locations (2)

Mansoura University; 🇪🇬 Mansoura, Dakhlia, Egypt

MansouraU; 🇪🇬 Mansoura, Egypt