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

NCT03063866 | Unknown Phase 4 DMC

• 1 other identifier: Sameh 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

• Level of sedation

  Level of sedation using Ramsay sedation agitation score at before induction of sedation

  6 months

Study Arms (2)

M group

ACTIVE COMPARATOR

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

Drug: Midazolam; Drug: Fentanyl

P Group

ACTIVE COMPARATOR

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

Drug: Propofol; Drug: Fentanyl

Interventions

Propofol DRUG

Propofol 1 mg/kg i.v

Also known as: propoven

P Group

Midazolam DRUG

Midazolam 3 mg i.v

Also known as: Dormicum

M group

Fentanyl DRUG

fentanyl 0.5 ug/kg

Also known as: Fantanyl

M group; P Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sherief Abd-Elsalam: lead
• Tanta University: collaborator

Study Sites (1)

Sherief Abd-Elsalam

Cairo, Egypt

RECRUITING

Related Publications (1)

• Ahmed SA, Selim A, Hawash N, Tawfik AK, Yousef M, Kobtan A, Badawi R, Elnawasany S, Elkhouly RA, Hanafy AS, Rizk FH, Mansour L, Abd-Elsalam S. Randomized Controlled Study Comparing Use of Propofol Plus Fentanyl versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients with Advanced Liver Disease. Int J Hepatol. 2017;2017:8462756. doi: 10.1155/2017/8462756. Epub 2017 Sep 26.

  PMID: 29312786 DERIVED

MeSH Terms

Conditions

Liver Diseases

Interventions

Propofol; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sameh Abdelkhalek Ahmed, MD

  Tanta University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Sherief Abd-Elsalam, MD

  Tanta university Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201095159522; Sheriefabdelsalam@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: February 21, 2017
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

EG (1)