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CTRI Number  CTRI/2022/06/043473 [Registered on: 24/06/2022] Trial Registered Prospectively
Last Modified On: 22/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Two different types of airway devices in gall bladder surgeries 
Scientific Title of Study   Comparison of oropharyngeal leak pressure of IGEL and Blockbuster LMA during laproscopic cholecystectomy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr S N medical collage, Jodhpur 
Address  Dr S N medical collage Jodhpur
MDM hospital, Dr S N medical collage, Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devdutt Sharma 
Designation  Junior Resident 
Affiliation  Dr S N medical collage, Jodhpur 
Address  Dr S N medical collage Jodhpur
P G BOYS Hostel, MDM Hospital, Dr S N medical collage, Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  9535702436  
Fax    
Email  devduttlawaniyan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr S N medical collage Jodhpur 
Address  Dr S N medical collage Jodhpur
MDM hospital, Dr S N medical collage, Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Source of Monetary or Material Support  
M D M Hospital Dr S N Medical College Jodhpur (Rajasthan) 
 
Primary Sponsor  
Name  M D M Hospital Dr S N Medical College Jodhpur 
Address  MDM Hospital Dr S N Medical College Shastri Nagar Jodhpur ( Rajasthan)  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrGeeta Singariya  MDM hospital, Dr. S.N. medical collage, Jodhpur  Main Operation Theatre Complex, First floor, M D M Hospital, Department Of Anaesthesiology And Critical Care, Dr S N Medical College Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 
9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group B (Blockbuster LMA)  The airway will be secured with Blockbuster LMA. Duration: 6 months 
Intervention  Group I (IGEL LMA)   The airway will be secured with I-Gel. Duration: 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists -Physical Status (ASA-PS) class I and II undergoing elective laparoscopic cholecystectomy under general anaesthesia. 
 
ExclusionCriteria 
Details  Any patient undergoing emergency surgery,
Pregnancy
With a prior history of abnormal anatomy of the larynx or pharynx,
Suspected difficult airway,
Patients with gastric reflex,
Increased risk of aspiration. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To determine the difference in Oropharyngeal leak pressure between I-gel and Blockbuster LMA at different time interval during laparoscopic cholecystectomy   2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the difference in LMA insertion parameters between I-gel and Blockbuster LMA (ease of insertion, insertion time, number of attempts, airway quality)
2.To determine any difference in hemodynamic changes during LMA insertion.
3.To determine the incidence and comparison of postoperative complications.
 
2 hours 
 
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   Phase 4 
Date of First Enrollment (India)   27/06/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 12-06-2022 and end date provided 30-06-2023?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study will be carried out in the Department of Anaesthesiology and Critical care, Dr S. N. Medical College, Jodhpur and associated group of hospitals after getting approval from the ethical committee and informed written consent from the study subjects. 

All patients in this study will be subjected to detailed pre-anaesthetic evaluation which includes: Present complaints, drug history, past history of surgical procedure under regional anaesthesia, history of nausea, retching or vomiting within the preceding 24 hrs, any major medical illness and drug history. Complete general physical examination and ASA grading will be done.  All investigations including complete blood profile, random blood sugar, blood urea, serum creatinine, coagulation profile, serum electrolytes, urine analysis, HIV, HBAg, Chest X-Ray PA view and ECG will be done prior to surgery. 

The night before surgery, all patients will be given orally omeprazole 20 mg, ranitidine 150 mg, and alprazolam 0.25 mg and advised to remain nil by mouth as per standard fasting protocol. On arrival of the patient in the operation theatre, the standard ASA non-invasive monitors like electrocardiogram (ECG), non-invasive blood pressure (NIBP) and peripheral oxygen saturation (SpO2) will be applied and the baseline vital parameters (Heart rate, SpO2, Blood pressure (systolic, diastolic, mean arterial pressure) will be recorded. The peripheral intravenous cannula will be secured with 18/20 G on the dorsum of the hand and lactated ringer (RL) solution will be started. The patients’ randomization will be done by computer-generated random number table and group allocation will be done by sealed opaque envelope method, which will be opened just before induction of anaesthesia.

The patient of both groups will be pre-medicated with Midazolam 0.05 mg/kg intravenously (IV) and fentanyl 2µg/kg IV. After preoxygenation for 3 minutes with 100% oxygen, anaesthesia will be induced with propofol 2-3 mg/kg IV till loss of eyelash reflex and no response to jaw thrust and. The airway will be secured 3 minutes after administration of atracurium 0.5 mg/kg IV by one of the airway devices as per study groups after application of 2% lignocaine jelly. The size will be chosen according to body weight. Both devices will be fixed by tapping the tube over the chin. 

Anaesthesia will be maintained with an oxygen/air mixture with Sevoflurane (0.6 to 2%) and Inj atracurium 0.1mg/kg using a closed circuit with a circle absorber. The patients will be ventilated with a tidal volume of 6-8 ml/kg at a respiratory rate between 14 and 16 bpm required to maintain normocapnia. During maintenance of anaesthesia, we will record oxygen saturation, HR, BP, end-tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, number of airway manipulations required, and the airway quality by performing neck auscultation and airway complications. At the end of the surgery, anaesthetic agents will be discontinued, and Inj neostigmine 0.05mg/ kg along with Inj glycopyrrolate 0.01mg/kg will be given to reverse the action of muscle relaxation. After the return of adequate spontaneous respiration and muscle power, the device will be removed once the patient is awake.

 
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