| CTRI Number |
CTRI/2025/12/098313 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using the Train of four test safely controls heart rate and blood pressure during anaesthesia |
|
Scientific Title of Study
|
A prospective comparative study of haemodynamic responses between clinical assessment guided intubation and train of four monitor guided intubation for patients undergoing elective surgery under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishneet Kaur Banga |
| Designation |
MD ANAESTHESIOLOGY |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical college |
| Address |
Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical college and Hospitals Salem Tamil Nadu
Salem
TAMIL NADU
636308
India |
| Phone |
8217632943 |
| Fax |
|
| Email |
ishneet.kaur09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VA Sabapathy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical college |
| Address |
Room number 15 Department of anaesthesiology Vinayaka Missions kirupananda variyar medical college
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VA Sabapathy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical college |
| Address |
Room number 15 Department of anaesthesiology Vinayaka Missions kirupananda variyar medical college
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions kirupanandar variyar medical college and hospital
Salem Tamil Nadu India
636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions kirupanandar variyar medical college and hospital |
| Address |
Vinayaka Missions kirupanandar variyar medical college and hospital Chinnaseeragapadi Salem
636308
Tamil nadu
India |
| Type of Sponsor |
Private 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 |
| Ishneet Kaur Banga |
Vinayaka Missions Kirupanandar Variyar medical college and hospital |
Vinayaka Missions Kirupanandar Variyar medical college and hospital
Chinnaseeragapadi
Salem
636308
Salem
TAMIL NADU |
8217632943
ishneet.kaur09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
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 |
Clinical assessment guided endotracheal intubation |
Group of patients will be intubated with endotracheal tube based on clinical assessment after induction |
| Comparator Agent |
Endotracheal intubation based on train of four response |
Group of patients posted for elective surgeries under general anaesthesia will be intubated after the train of four response on the TOF monitor is zero out of four |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to the American Society of Anaesthesiologists physical status I and II
Patients posted for elective surgery requiring general anaesthesia will be included in the study
18–60 years of age
Patients of either sex |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients belonging to the American Society of Anaesthesiologists physical status III and IV
Anticipated difficult airway Mallampati classification III and IV
Patients with hepatic renal cardiovascular neurological neuromuscular or other systemic diseases such as uncontrolled diabetes mellitus uncontrolled hypertension and patients on antipsychotic medications
Pregnant females |
|
|
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 primary objective is to compare the heart rate at different times before during and after intubation |
The primary objective is to compare the heart rate at different times before during and after intubation Time 0 baseline then 1 minute 2 minutes 3 minutes 4 minutes 5 minutes 6 minutes 7 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective is to compare the changes in mean arterial pressure MAP which will be evaluated in response to intubation The intubating conditions will be assessed using Kriegs intubating score, which ranges from 3 optimal intubating conditions to 12 least favorable conditions
The time between the administration of a neuromuscular blocking agent end of a 5-second infusion & endotracheal intubation end of a 5-second inflation of the sealing cuff
- Laryngoscopic views will be graded according to the CormackLehane CL classification
Number of attempts at intubation will also be recorded |
MAP will be recorded at Time 0 that is baseline 1 minute 2 minutes 3 minutes 4 minutes 5 minutes 6 minutes 7 minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/12/2025 |
| 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="0"
Days="0" |
|
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 - 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 - Informed Consent Form
- 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) -
- For how long will this data be available start date provided 16-12-2025 and end date provided 27-05-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Tracheal intubation triggers acute sympathetic nervous system activation manifesting as significant elevations in heart rate and blood pressure This haemodynamic surge carries clinical consequences in patients with cardiovascular compromise increasing myocardial ischemia risk and perioperative adverse events Quantitative neuromuscular monitoring using train of four TOF stimulation provides objective confirmation of complete neuromuscular blockade potentially optimizing intubating conditions and attenuating haemodynamic responses through reduced laryngeal trauma Current evidence comparing TOF guided versus clinical assessment intubation timing remains limited regarding haemodynamic outcomes and safety profiles |