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Status unknownNCT03466632Updated Mar 15, 2018

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

A Phase 3 interventional study of Propofol and Dexmedetomidine in Colonic Diseases, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-03-15.

Sponsored by Tanta University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Colonic Diseases

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03

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • aged 25-45 years,
  • ASA class I or II,
  • who are scheduled for elective outpatient colonoscopy

Exclusion criteria

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    • Propofol Group

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

    Drug: Propofol

  • Active comparator
    • 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

    Drug: Dexmedetomidine

Interventions

  • DrugPropofol

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

  • DrugDexmedetomidine

    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

05

What researchers measure

Primary outcomes

  1. Number of patients with adequate sedation

    the number of patients adequately sedated

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Sameh Abdelkhalek Ahmed
    Zagazig, 35455, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03466632
Lead sponsor
Tanta University
Responsible party
Sherief Abd-Elsalam (Principle investigator, Tanta University) — Principal investigator
First posted
Mar 15, 2018
Start date
Apr 1, 2016
Primary completion
Apr 1, 2020 (estimated)
Completion
Apr 1, 2020 (estimated)
Last update
Mar 15, 2018

Study contacts

Sherief Abd-Elsalam, MD
Contact
sheriefabdelsalam@yahoo.com
00201095159522
Sherief Abd-Elsalam, MD
study director · Tanta University
Sameh Abdelkhalek Ahmed, MD
study director · Tanta University Anasthesia Department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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