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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06358131
Enrollment
656
Registered
2024-04-10
Start date
2022-01-01
Completion date
2024-08-01
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Diseases

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.

Interventions

DEVICEEndoscopy

upper and lower endoscopy

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.2 yearsvisual analog scale

Countries

Egypt

Contacts

Primary ContactAsmaa Gameel, MD
asmaagameel165@gmail.com0201025835429

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026