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A Clinical trial to compare the efficacy of Propofol-Ketamine combination with Dexmedetomidine for performing Drug Induced Sleep Endoscopy(DISE) in patients of Obstructive Sleep Apnoea.

A Prospective Randomized study to compare the efficacy of Propofol-Ketamine combination with Dexmedetomidine for performing Drug Induced Sleep Endoscopy(DISE) in patients of Obstructive Sleep Apnoea.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012076
Enrollment
80
Registered
2018-02-22
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: null- Obstructive Sleep Apnoea

Interventions

Intervention1: Propofol-Ketamine Drug combination: The Drug Combination will be administered as intravenous infusion. Propofol will be started at a concentration of 2microgram/ml which will be increas

Sponsors

TATA Motors Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients who give their informed consent willingly. Clinical symptoms of snoring, morning headaches,tiredness,daytime sleepiness. ASA status 1-2. Apnoea-Hypopnea Index (AHI) score greater than 5 events per hour on Polysomnography. No active focus of infection in nose and throat. All patients who have previously failed to respond to conservative treatment for OSA, like changes in sleep position and sleep hygiene. Patients who were either intolerant or unwillingly to use continuous positive airway pressure therapy. Patients with no major systemic disease.

Exclusion criteria

Exclusion criteria: Age 60 years. Patients with high ASA score >3. Severe OSA (AHI >70 events/hour). Morbid Obesity BMI >30kg/m2. Patients with 2nd-3rd degree A-V block. Known allergies against the study drugs. Gross maxillary and mandibular deformities (mainly retrognathia) on lateral cephalometry. Patients with psychiatric disorders. Patients who have undergone previous surgical therapies for OSA. Mallampati score of 3-4. History of drug or alcohol abuse. History of chronic alcohol use.

Design outcomes

Primary

MeasureTime frame
Completion of Drug Induced Sleep Endoscopy in minimum time with diagnosis of site and degree of obstruction.Timepoint: Time to complete procedure Time from starting infusion till adequate depth of sedation is reached. Duration of DISE. Time for recovery. 0-no obstruction 1-Partial obstruction 2-Complete Obstruction Level of obstruction Velum Oropharynx lateral walls Tongue base Epiglottis

Secondary

MeasureTime frame
Haemodynamic and Respiratory parameters. Bispectral index. Complications of the procedure. Adverse effects of study drugs. Patient satisfaction and surgeon satisfaction.Timepoint: Haemodynamic and Respiratory parameters include Blood Pressure, Heart rate, Oxygen Saturation and respiratory rate. Monitoring will be done before, during and after the procedure. Patient and surgeon satisfaction will be measured on a scale of 0-10. 0 being not satisfied and 10 being highly satisfied.

Countries

India

Contacts

Public ContactDr Sangini Kumar

TATA Motors Hospital

shalabh.rastogi@tatamotors.com7209000103

Outcome results

None listed

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