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NCT Number: NCT03091894

Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

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.

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Key information

Conditions

Obstructive Sleep Apnea of Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zagazig university

Zagazig, Sharqia Province, 002055, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

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

Other names: diprivan

Dexmedetomidine

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

Other names: precedex

Primary outcomes

  1. success of sedation

    Time frame: 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 outcomes

  1. time until sufficient sedation

    Time frame: about 5-10 minutes from start of sedation

    time till patient is ready to start endoscopy

Sponsors and collaborators

Lead sponsor

Essam Fathi

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2017
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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