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 yet recruiting

Conditions: Obstructive Sleep Apnoea

Registration Number: CTRI/2018/02/012076

Lead Sponsor: TATA Motors Hospital

Brief Summary: The incidence of Sleep-Disordered Breathing, and specifically Obstructive Sleep Apnoea(OSA), has increased significantly over the last several decades.Patients with Obstructive Sleep Apnoea experience excessive daytime sleepiness, impaired concentration, snoring, recurring nocturnal awakenings and non-restorative sleep with an increased risk of obesity and cardiovascular disease leading to substantial socio-economic implications.

Diagnostic evaluation, thus, becomes crucial in choosing the best treatment option for OSA. Baseline evaluation, when integrated with polysomnography report and sleep endoscopy gives the complete information about pathophysiology of airway obstruction during sleep.

Currently, Drug induced Sleep Endoscopy (DISE) is the most reliable method to determine the level, number and severity of sites of obstruction of the airway in known cases of sleep apnoea and to specify the exact dynamic pattern of obstruction. DISE uses general anaesthesia to induce sleep which mimics natural sleep, thereby facilitating examination of upper airway obstruction. Reliable calculation of the required anaesthetic dose to achieve and maintain obstruction without causing prolonged loss of consciousness or oxygen desaturation and at the same time keeping the procedure short is challenging.

Midazolam and Propofol are the conventional sedative agents that are being used alone, or in combination, for DISE. Both drugs have their advantages and disadvantages. The disadvantage being inadequate sedation and desaturation. In this context, Dexmedetomidine, a new drug has proved to be a useful sedative agent as it causes minimal respiratory depression and allows faster post- procedure recovery.Literature supports the use of dexmedetomidine for DISE, but has not compared the results of dexmedetomidine with other anaesthetic agents. Studies have documented the use of ketamine for performing DISE in paediatric OSA patients. The advantage of using ketamine is that it ensures a higher rate of successful completion of procedure with less respiratory depression. Review of literature does not present with similar evidence which documents the use of ketamine in adult patients.

Through this study, we plan to evaluate the efficacy of two groups of anaesthetic agents for performing DISE in a randomised case study. 80 OSA patients undergoing DISE with general anaesthesia will be randomized into two groups.One group will receive propofol-ketamine infusion while the other group will receive dexmedetomidine infusion. DISE will be performed in the Operation theater. Hemodynamic and respiratory parameters will be recorded during the procedure at intervals of 5,10,15,20,25 and 30 minutes. The primary outcome will be time taken to successfully complete the procedure, site and severity of obstruction. The secondary outcome measures will include haemodynamic and respiratory parameters, Bispectral index score to assess the depth of induced sleep, Modified post -op Aldrete score, Complications of the procedure, adverse effects of the anaesthetic drugs that are being used in the study and patient and surgeon satisfaction score.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

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.	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 Outcome Measures

Name	Time	Method
Haemodynamic and Respiratory parameters.	Bispectral index.

Trial Locations

Locations (1): Department of Otorhinolaryngology and Head and Neck Surgery
🇮🇳
Singhbhum, JHARKHAND, India
Department of Otorhinolaryngology and Head and Neck Surgery
🇮🇳Singhbhum, JHARKHAND, India
Dr Sangini Kumar
Principal investigator
7004222606
sangini.smartlife@gmail.com