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

NCT ID: NCT03466632

Last Updated: 2018-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2020-04-01

Brief Summary

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

Detailed Description

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

Conditions

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Colonic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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• Propofol Group

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

• 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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherief Abd-Elsalam, MD

Role: STUDY_DIRECTOR

Tanta University

Sameh Abdelkhalek Ahmed, MD

Role: STUDY_DIRECTOR

Tanta University Anasthesia Department

Locations

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Sameh Abdelkhalek Ahmed

Zagazig, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, MD

Role: CONTACT

00201095159522

Facility Contacts

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Sameh Abdelkhalek Ahmed, MD

Role: primary

00201095159522

Other Identifiers

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dexmedetomidine colonoscopy

Identifier Type: -

Identifier Source: org_study_id

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