drugset / Trial / NCT03063866

Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.

NCT03063866 ↗

Phase 4 Unknown 100 enrolled Tanta University Tanta University · collab
RandomizedParallel-groupSingle-blindDiagnostic

Summary

Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver disease. It requires variable degree of sedation ranging from minimal sedation to general anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure. In conscious sedation, patients are able to make purposeful responses to auditory and tactile clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation, patients respond only to painful stimuli, and airway support is frequently required. At the level of general anesthesia, patients are unresponsive, and airway support is mandatory.

Timeline

Start
2017-02-21
Primary completion
2018-03
Completion
2018-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 3 mg Intravenous
Comparator Propofol Small molecule 1 mg/kg Intravenous
Comparator Fentanyl Other / unclassified 0.5 ug/kg Intravenous

Indications