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

Sherief Abd-Elsalam

Status and phase: Unknown; Phase 4

Conditions: Liver Diseases

Treatments: Drug: Midazolam; Drug: Fentanyl; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03063866

Sameh 1

Details and patient eligibility

About

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.

Full description

The aim of this study is to compare use of propofol or midazolam as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 40 and 60 years old.
• With Child score B or C
• Presented for elective gastrointestinal endoscopy

Exclusion criteria

• Emergent condition like hematemesis.
• Patients with moderate to severe hepatic encephalopathy.
• Patients with hepatopulmonary syndrome.
• Patients with known or suspected hypersensitivity to the used medication were also excluded from the study.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

M group

Active Comparator group

Description:

Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg

Treatment:

Drug: Fentanyl

Drug: Midazolam

P Group

Active Comparator group

Description:

Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v

Treatment:

Drug: Propofol

Drug: Fentanyl