| CTRI Number |
CTRI/2023/05/053289 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the use of Laryngeal Mask airway and Endotracheal tube for managing airway for patients undergoing endovascular neurosurgery under General anesthesia |
|
Scientific Title of Study
|
Comparison of Laryngeal Mask Airway versus Endotracheal Intubation in General Anaesthesia for Endovascular Neurosurgery : A Randomised Control Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa Kerketta Khurana |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesiology and Intensive Care, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871813837 |
| Fax |
|
| Email |
drdeepa.khurana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Kerketta Khurana |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesiology and Intensive Care, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871813837 |
| Fax |
|
| Email |
drdeepa.khurana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Kerketta Khurana |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesiology and Intensive Care, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871813837 |
| Fax |
|
| Email |
drdeepa.khurana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
VMMC and Safdarjung Hospital, New Delhi |
| 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 |
| Dr Deepa Kerketta Khurana |
VMMC and Safdarjung Hospital, New Delhi |
Department of Anaesthesiology and Intensive Care,
Department of Neurosurgery, DSA room
South
DELHI |
9871813837
drdeepa.khurana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I671||Cerebral aneurysm, nonruptured, (2) ICD-10 Condition: Q282||Arteriovenous malformation of cerebral vessels, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Use of endotracheal tube in general anaesthesia for endovascular neurosurgery |
Comparing changes in haemodynamics, airway safety and any adverse respiratory event between LMA versus endotracheal tube for general anaesthesia in endovascular neurosurgery |
| Intervention |
Use of Laryngeal Mask Airway in General Anaesthesia for endovascular neurosurgery |
Monitoring haemodynamic parameters, airway safety and adverse respiratory events using LMA for airway management in general anaesthesia for endovascular neurosurgery
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective endovascular treatment of cerebral arteriovenous malformations or aneurysms
2. American Society of Anaesthesiologists (ASA) I, II
3. Hunt and Hess – Grade 1-3
|
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway, Mallampati Score>3
2. Preoperative intubated patient
3. Allergy to any anaesthetic agent or drug(Injection Propofol or Injection Lignocaine)
4. Pregnancy
5. Intraoperative surgical complication
6. Severe cardiac, or renal disease, ASA >III
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the changes in hemodynamic parameters during intubation and extubation in between both study groups. |
At baseline, At 0,1,3,5,10 min after intubation and extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare respiratory complications in both study groups.
2. To compare preoperative and post operative neurological status.
|
Baseline and within 1 hour post surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study aims to compare endotracheal tube and laryngeal mask airway for airway management with respect to
haemodynamic stability, airway safety, adverse respiratory events and
preoperative versus postoperative neurological status in patients undergoing endovascular treatment of cerebral aneurysm under general anaesthesia. |