Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

NCT ID: NCT03091894

Last Updated: 2018-04-13

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-09

Study Completion Date

2018-04-08

Brief Summary

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This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.

Detailed Description

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Propofol is a commonly used intravenous anesthetic drug used for procedural sedation. Dexmedetomidine is an alpha 2 adrenergic receptor agonist which has a sedative and analgesic effects.In the current study the success of the sedation during drug induced sleep endoscopy will be assessed.

Conditions

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Obstructive Sleep Apnea of Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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propofol

patients will receive only propofol intravenous infusion for sedation

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

propofol intravenous infusion via syringe pump with loading dose of 0.5 mg/kg over 3 minutes then continuous infusion in a dose of 25-75 ug/kg/minute

propofol-dex.

patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

propofol intravenous infusion via syringe pump with loading dose of 0.5 mg/kg over 3 minutes then continuous infusion in a dose of 25-75 ug/kg/minute

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine intravenous infusion via syringe pump with loading dose of 0.5ug/kg over 5 minutes the continuous infusion in a dose of 0.2-0.7ug/kg/hour in addition to the propofol infusion as in propofol group

Interventions

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Propofol

propofol intravenous infusion via syringe pump with loading dose of 0.5 mg/kg over 3 minutes then continuous infusion in a dose of 25-75 ug/kg/minute

Intervention Type DRUG

Dexmedetomidine

dexmedetomidine intravenous infusion via syringe pump with loading dose of 0.5ug/kg over 5 minutes the continuous infusion in a dose of 0.2-0.7ug/kg/hour in addition to the propofol infusion as in propofol group

Intervention Type DRUG

Other Intervention Names

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diprivan precedex

Eligibility Criteria

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Inclusion Criteria

* age more than 18 years
* patients with obstructive sleep apnea
* ASA 1and2

Exclusion Criteria

* patient refusal
* age less than 18 years
* morbid obesity
* known or suspected allergy to the studied drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Essam Fathi

OTHER_GOV

Sponsor Role lead

Responsible Party

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Essam Fathi

assistent professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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essam f abdelgalel, A.professor

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

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Zagazig university

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3-2017-021

Identifier Type: -

Identifier Source: org_study_id

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