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

Gastrointestinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06358131
• Other study ID #: R.21.10.1493
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2023
• Source: Mansoura University
• Contact: Asmaa Gameel, MD
• Phone: 0201025835429
• Email: asmaagameel165[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 656
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Device:
• Endoscopy
upper and lower endoscopy

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakhlia
Egypt	MansouraU	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.	visual analog scale	2 years