Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy

Colonic Diseases Clinical Trial

Official title:

Randomised Study Comparing the Use of Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03466632
• Other study ID #: dexmedetomidine colonoscopy
• Status: Recruiting
• Phase: Phase 3
• First received: March 9, 2018
• Last updated: March 9, 2018
• Start date: April 1, 2016
• Est. completion date: April 1, 2020

Study information

• Verified date: March 2018
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, MD
• Phone: 00201095159522
• Email: sheriefabdelsalam[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Description:

Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• aged 25-45 years,

• ASA class I or II,

• who are scheduled for elective outpatient colonoscopy

Exclusion Criteria:

• refused to give informed consent

• if they had known hypersensitivity to the used drugs

• patients with morbidly obese patients

• patients with increased risk for airway obstruction as obstructive sleep apnea,

• Liver diseases

Related Conditions & MeSH terms

• Colonic Diseases

Intervention

Drug:
• Propofol
propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure.
• Dexmedetomidine
dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure

Locations

Country	Name	City	State
Egypt	Sameh Abdelkhalek Ahmed	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adequate sedation	the number of patients adequately sedated	6 months