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Clinical Trials/NCT06358131
NCT06358131
Recruiting
Phase 1

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

Mansoura University2 sites in 1 country656 target enrollmentJanuary 1, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Gastrointestinal Diseases
Sponsor
Mansoura University
Enrollment
656
Locations
2
Primary Endpoint
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.
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
August 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asmaa Gameel

Dr

Mansoura University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Time Frame: 2 years

Secondary Outcomes

  • Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.(2 years)

Study Sites (2)

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