To compare the two techniques of extubation techniques in laparotomy patients

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/09/045931
• Lead Sponsor: DrSathya NarayananK

Brief Summary

In adults following surgery under general anesthesia, conventional awake extubation is often employed as it assures intact airway reflexes and minimizes airway obstruction. But it carries disadvantages of hemodynamic disturbances like tachycardia , hypertension and myocardial infarction , respiratory disturbances like laryngospasm , coughing , bucking , straining and trauma like blood staining , postoperative sore throat ,agitation. The incidence of perioperative myocardial ischemia is also highest at the end of surgery and during the period of emergence.

 Rationale of this study :

 The ongoing COVID-19 pandemic has reinforced the need for minimizing aerosol generation during various airway management techniques. Awake extubation techniques often leads to greater aerosol generation than intubation due to coughing, straining, bucking etc. The Implications of Smooth extubation techniques are that it prevents aerosol generation and also leads to lesser variations in haemodynamic parameters and airway complications.

 A clear distinction between successful and smooth extubation has to be made. Successful extubation is wholly achieving control at respiratory level while smooth extubation involves smooth respiratory , hemodynamic and atraumatic conditions. Also the terms ‘Smooth Emergence’ and ‘Smooth Extubation’ are being used interchangeably as no consensus between the two exist .

 Many strategies are employed in smooth extubation strategies . These include Deep extubation , ‘No-Touch’ Extubation , ETT exchange  to LMA , addition  of Dexmedetomidine 0.5 -0.7mcg/kg infusion 15 minutes and inj.remifentanyl 0.03mcg/kg infusion 10 min before extubation ,pharmacological aids like Intracuff lidocaine , Intravenous lidocaine , calcium channel blockers .

This study compares deep extubation vs ‘No touch Awake extubation’ .The need to compare these two techniques is that they have not been compared together previously so as to find out which one is superior , easier to carry out and less time consuming and its effect on the duration of patient’s stay inside operation room .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-10
• Last Update Posted: 2023-05-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patient with written informed consent.
• ASA physical status I–II, adult.
• Patients, of both genders, aged between 18 and 45 years.
• Scheduled for elective laparatomy surgeries.
• BMI Range 18.5 – 24.9.

Exclusion Criteria

• Patient refusal. Body mass index 18.5.
• 25 kg/m2. Known or estimated difficult airway. Severe Respiratory disease , kidney disease, liver disease and cardiovascular disease .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cough between the two groups	baseine , 2 minutes , 5 minutes , 10 minutes , 15 minutes , 0 minutes

Secondary Outcome Measures

Name	Time	Method
Airway obstruction , secretions , bucking , episodes of desaturation , breath holding , laryngospasm , Tachycardia , Hypertension ,Myocardial ischemia ,time of return of consciousness of the patients between the two groups post end of surgery , need for supplemental oxygen , airway adjuncts , sore throat , hoarseness of voice , biting , non purposeful movements , oozing from the wound	baseline,2 minutes ,5 minutes ,10 minutes ,15 minutes ,20 minutes ,25 minutes ,30 minutes

Trial Locations

Locations (1)

ESIC MEDICAL COLLEGE , HOSPITAL AND PGIMSR; 🇮🇳 Chennai, TAMIL NADU, India

ESIC MEDICAL COLLEGE , HOSPITAL AND PGIMSR

🇮🇳Chennai, TAMIL NADU, India

DR SATHYA NARAYANANK

Principal investigator

9597447444

sathyavaan4444@gmail.com