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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03091894
Enrollment
50
Registered
2017-03-27
Start date
2017-04-09
Completion date
2018-04-08
Last updated
2018-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Dexmedetomidine, Sleep, Endoscopy, Propofol

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.

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.

Interventions

DRUGPropofol

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

DRUGDexmedetomidine

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

Sponsors

Essam Fathi
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
success of sedationthe duration of the procedure under sedation is usually about 20 minutesto complete the procedure with diagnosis of site and degree of obstruction

Secondary

MeasureTime frameDescription
time until sufficient sedationabout 5-10 minutes from start of sedationtime till patient is ready to start endoscopy

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026