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

NCT06358131 | Unknown Phase 1

• 1 other identifier: R.21.10.1493
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.

  2 years

Study Arms (2)

propofol arm

ACTIVE COMPARATOR

Device: Endoscopy

midazolam arm

ACTIVE COMPARATOR

Device: Endoscopy

Interventions

Endoscopy DEVICE

upper and lower endoscopy

midazolam arm; propofol arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Mansoura University

Al Mansurah, Dakhlia, 35516, Egypt

RECRUITING

MansouraU

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Asmaa Gameel, MD

CONTACT

0201025835429; asmaagameel165@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: April 10, 2024
• Study Start: January 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2023-05

Locations

EG (2)