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CTRI Number  CTRI/2024/09/073235 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Perioperative respiratory adverse events during deep verses awake extubation in pediatric population 
Scientific Title of Study   Periperative respiratory adverse events during deep versus awake extubation in pediatric patients - a single centered prospective randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raylene Dias 
Designation  Assistant Professor 
Affiliation  Seth GSMC and KEM hospital 
Address  Department of pediatric anesthesia, Seth GSMC and KEM Hospital, Parel, Mumabai

Mumbai
MAHARASHTRA
400012
India 
Phone  9930608191  
Fax    
Email  raylene.dias@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anu K A 
Designation  Senior Resident 
Affiliation  Seth GSMC and KEM Hospital 
Address  Department of Pediatric anesthesia, 3rd floor, old building, KEM Hospital ,Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  08450970818  
Fax    
Email  anukaaluva@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anu K A 
Designation  Senior Resident 
Affiliation  Seth GSMC and KEM Hospital 
Address  Department of Pediatric Anesthesia , near ward 3, 3 rd floor , old hospital building, KEM Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  08450970818  
Fax    
Email  anukaaluva@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric Anesthesia , Seth GSMC and KEM hospital, Parel, Mumbai, India, 400012. 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [No sponser] 
 
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 Anu K A  Seth GSMC and KEM Hospital  pediatric surgery operation theatre, Near ward no 3, 3 rd floor, Old building, Seth GSMC and KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA 		 8450970818

anukaaluva@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 2 relating to Biomedical and Health Research, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India. Established - 14 th November 2008  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  Awake Extubation  Awake extubation in pediatric surgery patients in pediatric operation theater during the duration of study of 1 year 
Intervention  Deep Extubation  Deep Extubation in pediatric operation theatre study participants during the study duration of 1 year 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Asa 1 and 2 patients posted for elective abdominal and urological procedures of less than 4 hours duration. 
 
ExclusionCriteria 
Details  Children less than 60 weeks post conceptional age, reactive airway disease, full stomach and high risk of aspiration, severe OSA, BMI more than 95 or less than 5th centile, craniofacial anomaly, any trauma or difficult airway, hemodynamic or metabolic abnormality. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Major airway complications at emergence that will be recorded are desaturation, laryngospasm, bronchospasm, regurgitation, stridor, persistent coughing, negative pressure pulmonary edema.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of minor airway complications like cough, breath holding, increased airway secretions, tube biting and minor airway obstruction.
Other parameters are hemodynamic variations, emergence delerium, need of oxygen and airway support in PACU,need for admission in ICU  		 1 year 
 
Target Sample Size   Total Sample Size="218"
Sample Size from India="218" 
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)   15/09/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 [anukaaluva@gmail.com].

  6. For how long will this data be available start date provided 16-08-2024 and end date provided 16-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Tracheal extubation is a critical event during emergence from anesthesia and the complications arising at extubation may lead to significant morbidity. Aim of this study is to compare the incidence of airway complications between awake and deep extubation with respect to major perioperative respiratory adverse events. Study will be prospective randomised controlled trial and will be conducted in children posted for short duration urological and general surgery procedures. 
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