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Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

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ClinicalTrials.gov Identifier: NCT03091894
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Essam Fathi, Zagazig University

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Drug: Propofol Drug: Dexmedetomidine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea: A Prospective Randomized Controlled Trial
Actual Study Start Date : April 9, 2017
Actual Primary Completion Date : April 8, 2018
Actual Study Completion Date : April 8, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: precedex




Primary Outcome Measures :
  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 Outcome Measures :
  1. time until sufficient sedation [ Time Frame: about 5-10 minutes from start of sedation ]
    time till patient is ready to start endoscopy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091894


Locations
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Egypt
Zagazig university
Zagazig, Sharkia, Egypt, 002055
Sponsors and Collaborators
Essam Fathi
Investigators
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Principal Investigator: essam f abdelgalel, A.professor Zagazig University

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Responsible Party: Essam Fathi, assistent professor, Zagazig University
ClinicalTrials.gov Identifier: NCT03091894     History of Changes
Other Study ID Numbers: 3-2017-021
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Essam Fathi, Zagazig University:
Dexmedetomidine
Sleep
Endoscopy
Propofol
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action