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

Mansoura University

Status and phase: Enrolling; Phase 1

Conditions: Gastrointestinal Diseases

Treatments: Device: Endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06358131

R.21.10.1493

Details and patient eligibility

About

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.

Enrollment: 656 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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656 participants in 2 patient groups

propofol arm

Active Comparator group

Treatment:

Device: Endoscopy

midazolam arm

Active Comparator group

Treatment:

Device: Endoscopy