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.

Not Applicable

• Conditions: Health Condition 1: null- Obstructive Sleep Apnoea

• Registration Number: CTRI/2018/02/012076
• Lead Sponsor: TATA Motors Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Age < 18 years and >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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Haemodynamic and Respiratory parameters. <br/ ><br>Bispectral index. <br/ ><br>Complications of the procedure. <br/ ><br>Adverse effects of study drugs. <br/ ><br>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. <br/ ><br>Patient and surgeon satisfaction will be measured on a scale of 0-10. <br/ ><br>0 being not satisfied and 10 being highly satisfied.