| CTRI Number |
CTRI/2025/04/084319 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Hemodynamic Stress Responses: Conventional Awake Extubation vs. I-Gel® Exchange Extubation in Craniotomy Surgeries |
|
Scientific Title of Study
|
A Randomized Study To Compare The Hemodynamic Stress Response Between Conventional Awake Extubation Of Endotracheal Tube And I-GEL® Exchange Extubation During Emergence From General Anaesthesia In Craniotomy Surgeries
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Huda Subair |
| Designation |
DNB RESIDENT,ANAESTHESIOLGY |
| Affiliation |
RUKMANI BIRLA HOSPITAL, A UNIT OF CMRI , JAIPUR |
| Address |
DEPARTMENT OF ANAESTHESIA
FIRST FLOOR
CK BIRLA HOSPITALS,RBH
GOPALPURA BYPASS ROAD
NEAR TRIVENI FLYOVER
GOPALPURA
JAIPUR
Jaipur
RAJASTHAN
302018
India |
| Phone |
8289907933 |
| Fax |
|
| Email |
drhudasubair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Baid |
| Designation |
Additional Director, Department of Anaesthesia |
| Affiliation |
RUKMANI BIRLA HOSPITAL, A UNIT OF CMRI , JAIPUR |
| Address |
Rukmani Birla Hospital, Gopalpura Bypass Road, Near Triveni Bridge, Gopalpura, Jaipur
Jaipur
RAJASTHAN
302018
India |
| Phone |
9828119109 |
| Fax |
|
| Email |
drruchibaid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HUDA SUBAIR |
| Designation |
DNB RESIDENT,ANAESTHESIOLGY |
| Affiliation |
RUKMANI BIRLA HOSPITAL, A UNIT OF CMRI , JAIPUR |
| Address |
Rukmani Birla Hospital, Gopalpura Bypass Road, Near Triveni Bridge, Gopalpura, Jaipur
Jaipur
RAJASTHAN
302018
India |
| Phone |
8289907933 |
| Fax |
|
| Email |
drhudasubair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rukmani Birla Hospital,A unit of Calcutta Medical Research Institute |
|
|
Primary Sponsor
|
| Name |
Rukmani Birla Hospital |
| Address |
Rukmani birla hospital,a unit of CMRI
Jaipur
302018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Huda Subair |
RUKMANI BIRLA HOSPITAL |
Department of Anaesthesia, Gopalpura Bypass Rd, Near Triveni Flyover, Shanthi Nagar, Gopal Pura Mode, Jaipur, Rajasthan 302018
CK Birla Hospitals RBH,
Jaipur
RAJASTHAN |
8289907933
drhudasubair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUKMANI BIRLA HOSPITAL INSTITUIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, (2) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Awake Extubation of Endotracheal Tube |
After completion of craniotomy surgery under general anaesthesia ,patient is extubated in the conventional manner. |
| Intervention |
I-GEL® Exchange Extubation Technique |
Before extubation, an appropriately sized I-gel® will be placed behind the tracheal tube, while the lungs are ventilated with the maintenance mixture and end tidal sevoflurane concentration is maintained at 0.6 -1.2%. Lubricated gastric tube is inserted through the gastric channel so as to ensure correct placement of SAD and also to prevent aspiration. After confirmation of adequate placement of SAD clinically and the correct placement of I-gel® with adequate chest rise and via capnography, the ventilation is continued. An assistant then deflates the tracheal tube cuff and removes the endotracheal tube while maintaining positive pressure. Thus, patient is allowed to be ventilated through the I-gel® as muscle relaxation is reversed . Once the patient is awake and breathing spontaneously, the I-gel® is removed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
With consent for the procedure, ASA grade 1 & 2,Age group 18 to 60 years,Modified Mallampati grade 1 and 2, Undergoing general anaesthesia for elective craniotomy surgeries,Tumor size less than 4cm,Aneurysm,Modified Fischer grade 1 or 2,Surgical duration less than 4 hours,Blood loss less than 400ml,Fasting greater than or equal to 8 hours,BMI less than 30 |
|
| ExclusionCriteria |
| Details |
Refusal to give consent,History of allergic drug reaction to any of the proposed drugs set to be used during the procedure,Patients with anticipated difficult intubation,Glasgow coma score less than 15, ASA grade 3,4 and 5, Patients with signs of increased ICP
Volumes greater than 1.5ml per kg on ultrasound guided gastric antrum examination, History of congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, acute respiratory distress syndrome, psychiatric illness, bleeding disorder, hepatic or renal dysfunction
Patients who may need elective mechanical ventilation post operatively
Patients who are receiving IV beta blockers
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change in Heart Rate,Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Blood Pressure. |
The parametres were measured At the end of surgery, After reversal, 1 minute after reversal, 3 minutes after reversal, 5 minutes after reversal, 10 minutes after reversal, 15 minutes after reversal,1 hour post operatively and 6 hours post operatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the total doses of intravenous Diltiazem required in each group to maintain hemodynamic parameters (Heart Rate & Mean Arterial Pressure) within 20% of baseline values during the extubation period.
To evaluate the incidence of respiratory complications following withdrawal of general anaesthesia, such as bucking, coughing, desaturation, laryngospasm, & pulmonary edema. |
Intravenous Diltiazem will be administered At the end of surgery, after reversal, 1 minute after reversal,3 minutes after reversal, 5 minutes after reversal, 10 minutes after reversal & 15 minutes after reversal.
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 (Others) - BY CONTACTING VIA EMAIL: drhudasubair@gmail.com
- For how long will this data be available start date provided 07-02-2025 and end date provided 07-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This randomized comparative study aims to compare the hemodynamic stress response between conventional awake extubation of endotracheal tube (ETT) and I-gel® exchange extubation during emergence from general anesthesia in craniotomy surgeries. The study includes 70 patients undergoing elective craniotomy surgeries, divided into two groups: Group A (conventional awake endotracheal extubation, n=35) and Group B (extubation using Bailey’s maneuver over I-gel®, n=35). The study will be conducted at the department of Anesthesiology, C. K. BIRLA Hospital, RBH, Jaipur. |