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Effects of addition of low dose of one medicine (midazolam) before operation on other medicines used for sedation (propofol- dexmedetomidine combination) for endoscopic sleep study in obstructive sleep apnea patients

Effects of addition of low dose midazolam to propofol dexmedetomidine based sedation for drug induced sleep endoscopy in obstructive sleep apnea patients - a randomised double blind, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030128
Enrollment
40
Registered
2020-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G473- Sleep apnea

Interventions

Intervention1: Midazolam: low dose midazolam (0.02mg/kg) as premedication Control Intervention1: normal saline: in control group

Sponsors

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing Drug Induced Sleep Endoscopy (DISE) procedure 2.ASA physical status of I and I 3.Aged 18-65 years of both males and females

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Known or suspected allergy to the studied drugs 3. ASA physical status of III or more 4. Pregnancy 5. Psychiatric or emotional disorder 6. History of addiction to opioids or sedatives 7. Have undergone previous upper airway surgery for OSA

Design outcomes

Primary

MeasureTime frame
To evaluate dose reduction of propofol with addition of low dose midazolam to propofol- dexmedetomidine based sedationTimepoint: intraoperative—

Secondary

MeasureTime frame
Recovery time Timepoint: postoperative;Episodes of haemodynamic instabilityTimepoint: intraoperative and postoperative (till 240minutes);Incidence of oxygen desaturationTimepoint: intraoperative and postoperative (till 240minutes);Procedure durationTimepoint: intraoperative;Successful completion of procedure Timepoint: intraoperative;Surgeonâ??s and patientâ??s satisfactionTimepoint: intraoperative and postoperative;Time to achieve sufficient sedation Timepoint: intraoperative—

Countries

India

Contacts

Public ContactDr Suman Arora

Post Graduate Institute of Medical Education and Research, Chandigarh

drsumanarora@hotmail.com7087009528

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026