Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea of Adult
• Interventions: Drug: Propofol; Drug: Dexmedetomidine

• Registration Number: NCT03091894
• Lead Sponsor: Essam Fathi

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Study Start: 2017-04-09
• Status Verified: 2018-04
• Primary Completion: 2018-04-08
• Study Completion: 2018-04-08
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• patient refusal
• age less than 18 years
• morbid obesity
• known or suspected allergy to the studied drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol-dex.	Propofol	patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation
propofol	Propofol	patients will receive only propofol intravenous infusion for sedation
propofol-dex.	Dexmedetomidine	patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation

Primary Outcome Measures

Name	Time	Method
success of sedation	the duration of the procedure under sedation is usually about 20 minutes	to complete the procedure with diagnosis of site and degree of obstruction

Secondary Outcome Measures

Name	Time	Method
time until sufficient sedation	about 5-10 minutes from start of sedation	time till patient is ready to start endoscopy

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Sharkia, Egypt