Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

NCT03091894 | Completed Phase 4

• 1 other identifier: 3-2017-021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Dexmedetomidine; Sleep; Endoscopy; Propofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• time until sufficient sedation

  about 5-10 minutes from start of sedation

Study Arms (2)

propofol

ACTIVE COMPARATOR

patients will receive only propofol intravenous infusion for sedation

Drug: Propofol

propofol-dex.

ACTIVE COMPARATOR

patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation

Drug: Propofol; Drug: Dexmedetomidine

Interventions

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

Also known as: diprivan

propofol; propofol-dex.

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

Also known as: precedex

propofol-dex.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Essam Fathi: lead

Study Sites (1)

Zagazig university

Zagazig, Sharqia Province, 002055, Egypt

Location

MeSH Terms

Interventions

Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• essam f abdelgalel, A.professor

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistent professor

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: April 9, 2017
• Primary Completion: April 8, 2018
• Study Completion: April 8, 2018
• Last Updated: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)