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CTRI Number  CTRI/2022/09/045931 [Registered on: 27/09/2022] Trial Registered Prospectively
Last Modified On: 20/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the two techniques of extubation techniques in laparotomy patients 
Scientific Title of Study   A comparative study of smooth extubation strategies - deep extubation versus no-touch awake extubation in adults undergoing laparotomy surgeries  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SATHYA NARAYANAN K 
Designation  ASSISTANT PROFESSOR  
Affiliation  ESIC MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA
ESIC MEDICAL COLLEGE , KK NAGAR CHENNAI
Chennai
TAMIL NADU
600078
India 
Phone  9597447444  
Fax    
Email  sathyavaan4444@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SATHYA NARAYANAN K 
Designation  ASSISTANT PROFESSOR  
Affiliation  ESIC MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA
ESIC MEDICAL COLLEGE , KK NAGAR , CHENNAI
Chennai
TAMIL NADU
600078
India 
Phone  9597447444  
Fax    
Email  sathyavaan4444@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SATHYA NARAYANAN K 
Designation  ASSISTANT PROFESSOR  
Affiliation  ESIC MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA
ESIC MEDICAAL COLLEGE , KK NAGAR , CHENNAI
Chennai
TAMIL NADU
600078
India 
Phone  9597447444  
Fax    
Email  sathyavaan4444@gmail.com  
 
Source of Monetary or Material Support  
Esic Medical college and pgimsr  
 
Primary Sponsor  
Name  DrSathya NarayananK 
Address  DEPARTMENT OF ANAESTHESIOLOGY , ESIC MEDICAL COLLEGE ,PGIMSR AND HOSPITAL , CHENNAI 600078 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SATHYA NARAYANANK  ESIC MEDICAL COLLEGE , HOSPITAL AND PGIMSR  Department Of Anaesthesia , 1st floor , B block , Esic medical college
Chennai
TAMIL NADU 
9597447444

sathyavaan4444@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Deep extubation   In group Deep extubation , the fraction of inspired oxygen (FiO2) will be increased to 100% and the end inspired concentration of inhaled anaesthetic will be adjusted to be at least 1 Minimum Alveolar Concentration (MAC) or higher if needed. The depth of anaesthesia will be considered adequate when the patient is spontaneously breathing with a regular pattern, at a MAC of 1 or higher, and if the patient did not show any response to suctioning and to deflation and re-inflation of the endotracheal tube cuff. Before extubation, an oral airway will be placed in all the patients, and jaw thrust will be applied if needed after extubation. The oral airway will be removed, either in the operating room by anaesthesia provider or in PACU by trained PACU nursing staff with 1-to-1 nurse to patient ratio under the supervision of an anaesthesiologist, when the patient regained airway reflexes. Patients will be administered oxygen at 6 L/min, via a face mask; supplemental oxygen will be discontinued in PACU as per usual recovery room management. the total duration of the thesis is 1 year and 3 month .  
Intervention  no-touch awake extubation  In group (no touch” awake extubation), at the end of the procedure, while the patient is still adequately anesthetized, any blood and secretions in the pharynx will be carefully suctioned under direct visualization in order to confirm that secretion clearance is complete and to avoid trauma to the mucosa, the ETT cuff will be deflated, and then the patients will be turned to the lateral (recovery) position. Only after this, sevoflurane will be discontinued and fresh gas flow will be increased, and if the patient did not breathe spontaneously, positive pressure ventilation will be continued with 100% oxygen until spontaneous ventilation returned. Tracheal extubation will be performed when patients had same criteria of group (I), but absolutely no stimulation “no touch” will be allowed until patients spontaneously woke up and were able to open their eyes, the anesthetist will only be allowed to call their name or give a simple verbal command to open their eyes, without physically stimulating the patient. the total duration of the thesis is 1 year and 3 month . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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 .

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cough between the two groups   baseine , 2 minutes , 5 minutes , 10 minutes , 15 minutes , 0 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
RESEARCH  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sathyavaan4444@gmail.com].

  6. For how long will this data be available start date provided 01-10-2022 and end date provided 28-02-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
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 .

 
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