| CTRI Number |
CTRI/2025/04/084494 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of exchange extubation by using medical device (I -gel) inserted just after end of surgery post removal of Endotracheal tube when patient is in deep state of anaesthesia (unconciuos) with traditional awake endotracheal tube extubation . |
|
Scientific Title of Study
|
Effect of exchange extubation using I-gel over traditional
awake extubation on vital parameters and quality of extubation . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwaray Gadhawe |
| Designation |
Junior Resident |
| Affiliation |
Gandhi Medical College BHOPAL |
| Address |
2nd floor, block 1,Department of Anaesthesiology, Gandhi Medical College and associated Hamidia Hospital , BHOPAL
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9011566425 |
| Fax |
|
| Email |
aishwarygadhawe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikas Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
Gandhi Medical College BHOPAL |
| Address |
2nd floor, block 1,Department of Anaesthesiology, Gandhi Medical college and associated Hamidia Hospital, BHOPAL
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9229988164 |
| Fax |
|
| Email |
1074vicky@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College BHOPAL |
| Address |
2nd floor, block 1,Department of Anaesthesiology, Gandhi Medical College and associated Hamidia Hospital, BHOPAL
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7898169898 |
| Fax |
|
| Email |
pandeyvandana92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical college ,Bhopal ,462001 , India |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College Bhopal |
| Address |
2nd floor,block 1 , Department of Anaesthesiology, Gandhi Medical College Bhopal ,462001, INDIA |
| 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 |
| DrVikas Kumar Gupta |
Hamidia hospital |
Operation theater block, 2nd floor,block 1 ,Gandhi medical college ,Bhopal ,462001,India
Bhopal
MADHYA PRADESH |
9229983164
1074vicky@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 |
Endotracheal tube extubation |
at the end of surgical procedure, vital parameters will be noted and Inhalational agent and N2O will be discontinued. Neostigmine 0.05- 0.07 mg/kg and glycopyrrolate 0.01 mg/kg
intravenously will be used to reverse the effect of
Relaxant. When the patient will generate tidal volume of 4ml/kg, EtCO2 40 mmHg and will respond to verbal commands, ETT extubation will be done and vital parameters will be noted. |
| Intervention |
Exchange Insertion of i-gel |
end of surgical procedure, vital parameters will be recorded, oropharynx will be
suctioned. Then ETT will be removed under the
laryngoscopy in deep anaesthesia, vital parameters
will be recorded and I-gel will be placed. I- gel will be
connected to breathing circuit, position will be
confirmed by auscultation, capnography and exhaled
tidal volume . Inhalational agent and N2O will be
discontinued,IV Neostigmine 0.05-0.07 mg/kg and
IV Glycopyrrolate 0.01 mg/kg will be given to reverse
the effect of relaxant. When the patient will
generate tidal volume of 4ml/kg, EtCO2 40 mmHg
and will respond to verbal commands, I-gel extubation will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II
Elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Emergency surgery
Contraindications for I-gel insertion
Obese patients
Difficult airway patients
Oral cavity/throat surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters |
Vitals are to be monitored after end of surgery,after exchange , 5/10/15 minutes after extubation /removal of i-gel |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Respiratory parameters
2.Time interval between end of surgery and extubation of endotracheal tube/ i-gel
3.Extubation quality score |
Secondary parameters are to be monitored till 15 minutes after extubation/removal of i-gel |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 3 |
|
Date of First Enrollment (India)
|
28/04/2025 |
| 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="11"
Days="30" |
|
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 - NO
|
|
Brief Summary
|
The approval of the hospital ethics and scientific committee will be obtained and the written and informed consent of the patient will be taken. All the patients will be kept NBM for 6 hours preoperatively. Airway examination of the patients according to standard protocol will be done.On arrival in the operation theatre, routine monitoring will be done and baseline. General anaesthesia with endotracheal intubation will be given as per standard protocol.In group 1, at the end of surgical procedure, vital parameters will be noted, ETT extubation will be Done. In group 2, at the end of surgical procedure, vital Parameters will be recorded, oropharynx will be suctioned. Then ETT will be removed under the laryngoscopy in deep anaesthesia and I-gel will be placed. I- gel will be connected to breathing circuit. I-gel extubation is done.
Vital parameters will be recorded for both groups after 5minutes, 10minutes and 15minutes of extubation. Respiratory parameters such as bucking, coughing and Sore throat will be observed for both groups till 15 minutes after extubation
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