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