Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Drug: Propofol; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 002055
      • Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: propofol; patients will receive only propofol intravenous infusion for sedation	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; Other Names: diprivan
Active Comparator: propofol-dex.; patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation	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; Other Names: diprivan; 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; Other Names: precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
time until sufficient sedation	time till patient is ready to start endoscopy	about 5-10 minutes from start of sedation

Collaborators and Investigators

• Sponsor: Essam Fathi
• Investigators: Principal Investigator: essam f abdelgalel, A.professor, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2017
• Primary Completion (Actual): April 8, 2018
• Study Completion (Actual): April 8, 2018

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Sleep; Endoscopy; Propofol; Dexmedetomidine
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 3-2017-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No