Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091894
• Other study ID #: 3-2017-021
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2017
• Last updated: April 11, 2018
• Start date: April 9, 2017
• Est. completion date: April 8, 2018

Study information

• Verified date: April 2018
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 8, 2018
• Est. primary completion date: April 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Zagazig university	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Essam Fathi

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success of sedation	to complete the procedure with diagnosis of site and degree of obstruction	the duration of the procedure under sedation is usually about 20 minutes
Secondary	time until sufficient sedation	time till patient is ready to start endoscopy	about 5-10 minutes from start of sedation