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
|
|
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
|
|
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
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [geetamanojkamal@gmail.com].
- 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.
- 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, HBs Ag, 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. |