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
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sathyavaan4444@gmail.com].
- 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.
- 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 . |