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CTRI Number  CTRI/2023/12/060731 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 21/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study how endotracheal tube cuff deflation affect extubation in surgeries of middle ear 
Scientific Title of Study   Effects of Pace of Endotracheal Tube Cuff Deflation On Cough Reflex During Extubation In Patients Undergoing Middle Ear Surgery:A Randomised Control Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrGini M George 
Designation  PG Student 
Affiliation  MOSC Medical college,Ernakulam 
Address  Department of Anaesthesia and critical care MOSC Medical College Hospital,Kolenchery Ernakulam,Kerala

Ernakulam
KERALA
682311
India 
Phone  6238295709  
Fax    
Email  marymanayath123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sara Vergis 
Designation  Professor 
Affiliation  MOSC Medical college,Ernakulam 
Address  Department of Anaesthesia and critical care MOSC Medical College Hospital,Kolenchery Ernakulam,Kerala

Ernakulam
KERALA
682311
India 
Phone  9446596066  
Fax    
Email  skorula@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrGini M George 
Designation  PG Student 
Affiliation  MOSC Medical college,Ernakulam 
Address  Department of Anaesthesia and critical care MOSC Medical College Hospital,Kolenchery Ernakulam,Kerala

Ernakulam
KERALA
682311
India 
Phone  6238295709  
Fax    
Email  marymanayath123@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Critical care MOSC Medical college Kolenchery Ernakulam Kerala 
 
Primary Sponsor  
Name  Malankara Orthodox Syrian Church Medical College 
Address  Malankara Orthodox Syrian Church Medical College Kolenchery Ernakulam 
Type of Sponsor  Private medical college 
 
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 Gini M George  Malankara Orthodox Syrian Church Medical College  Department of Anaesthesiology Malankara Orthodox Syrian Church Medical College Kolenchery
Ernakulam
KERALA 		 6238295709

marymanayath123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Malankara Orthodox Syrian Church Medical CollegeInstitutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H729||Unspecified perforation of tympanic membrane,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Rapid deflation of endotracheal tube cuff deflation  Rapid deflation of endotracheal tube cuff deflation in 1-3 seconds during extubation 
Intervention  Slow endotracheal tube cuff deflation  Slow deflation of endotracheal tube cuff at a rate of 1ml/second during extubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA physical status I or II
Patients undergoing middle ear surgeries under general anaesthesia
Duration of surgery more than 1 hour and less than 6 hours 
 
ExclusionCriteria 
Details  Body mass index < 19 kg/m2 or > 30 kg/m2
Mallampati classification III or IV
Pre existing sore throat,hoarseness,cough or laryngeal mucosal haemorrhage
More than one attempt at intubation during induction
Delayed emergence (inability to regain an adequate level of counsciousness ,unresponsive or deeply sedated over 60 min from the last administration of anaesthetic agents)
Asthma ,chronic obstructive pulmonary disease ,smoking ,anxiety disorder. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of cough reflex during extubation  During extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Severity of cough reflex & hemodynamic changes during cuff deflation  During extubation
Blood pressure & heart rate at extubation,after 5 mins,10 mins 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   Phase 4 
Date of First Enrollment (India)   31/12/2023 
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)   Not Yet Recruiting 
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 - NO
Brief Summary   This study is to assess the incidence and severity of cough reflex after continuously and slowly deflating endotracheal tube cuff at a rate of 1ml/second compared to rapid deflation during extubation in patients undergoing middle ear surgeries.
A randomised controlled trial will be conducted over a period of 1 year and 6 months on 76 patients of ASA I-II status, in the age group of 18-65 years undergoing middle ear surgery .All patients will be subjected to preanesthetic evaluation ,the study will be explained in detail and written informed consent will be obtained.
Patients enrolled for this study will be randomised into two groups of 38 each, using computer generated random numbers .Before induction of anaesthesia, the opaque envelope containing group allocation is opened and the group to which that patient is allotted will be determined.
Patient will be induced with Injection Fentanyl 2 mcg/kg ,Propofol 2 mg/kg. Laryngoscopy and endotracheal intubation will be done .The endotracheal tube cuff is inflated with 5-8 ml air and cuff pressure is maintained 25-30 cm of H2O . Anaesthesia will be maintained with oxygen,air and sevoflurane.
During extubation ,cuff is deflated as follows,
Group A-Deflation at a rate of 1ml/second 
Group B-Rapid deflation
The incidence and severity of cough reflex using numerical scoring system at extubation and  hemodynamic changes during extubation at 1min,5 min and 10 min will be assessed.Data will be summerised by using descriptive statistics.
 
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