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Clinical Trials/NCT03466632
NCT03466632
Unknown
Phase 3

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

Tanta University1 site in 1 country100 target enrollmentApril 1, 2016

Overview

Phase
Phase 3
Intervention
Propofol
Conditions
Colonic Diseases
Sponsor
Tanta University
Enrollment
100
Locations
1
Primary Endpoint
Number of patients with adequate sedation
Last Updated
8 years ago

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
April 1, 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sherief Abd-Elsalam

Principle investigator

Tanta University

Eligibility Criteria

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

Arms & Interventions

• Propofol Group

propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..

Intervention: Propofol

• Dexmedetomidine Group

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

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

Number of patients with adequate sedation

Time Frame: 6 months

the number of patients adequately sedated

Study Sites (1)

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