| CTRI Number |
CTRI/2024/01/061704 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of blocking a nerve in throat before putting a tube in airway on blood pressure in patients with high blood pressure. |
|
Scientific Title of Study
|
Effect of ultrasound-guided superior laryngeal nerve block as an adjuvant to general anaesthesia on hemodynamic response to intubation in hypertensive patients: A randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krisnendu Sen |
| Designation |
Junior Resident Postgraduate |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
| Address |
Room no. 326, 4th floor, P block, New Doctors Hostel, Department of Anaesthesia, Post Graduate Institute of Medical Education and Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
07001376442 |
| Fax |
|
| Email |
krisnendu28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prerna Varma |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
| Address |
4th floor, A-block, Department of Anaesthesia, Post Graduate Institute of Medical Education and Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09654238627 |
| Fax |
|
| Email |
prerna.varma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prerna Varma |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
| Address |
4th floor, A-block, Department of Anaesthesia, Post Graduate Institute of Medical Education and Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09654238627 |
| Fax |
|
| Email |
prerna.varma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh. |
|
|
Primary Sponsor
|
| Name |
Dr YLN |
| Address |
4th floor, A block, Department of Anaesthesia, Post Graduate Institute of Medical Education and Research, Chandigarh. |
| 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 Prerna Varma |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
Madhya Marg, Sector 12, Chandigarh, 160012.
Chandigarh
CHANDIGARH |
09654238627
prerna.varma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PGIMER,Chandigarh |
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 |
No block technique with standard intravenous induction |
No block |
| Intervention |
Ultrasound guided superior laryngeal nerve block with intravenous induction |
USG-guided iSLN block procedure:
• Strict aseptic precaution will be taken, patient will be positioned with neck extension.
• High frequency (6-13 MHz) linear ultrasound probe will be used.
• 25 gauge 1-inch needle with a 5 ml syringe containing 2% lignocaine (4 ml) will be taken.
• Probe will be placed in transverse plane and needle will be guided using in-plane method.
• 2 ml of 2% lignocaine will be injected bilaterally.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Controlled Hypertension/Hypertension with Diabetes/Hypertension with Coronary Artery Disease
2.Elective surgery requiring endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1. Refusal to consent
2. ASA I/III/IV
3. Airway surgeries or surgeries requiring airway manipulation.
4. Any cardiomyopathy or ventricular dysfunction
5. Presence of any predictor of difficult intubation
6. Requirement of more than 2 attempts at endotracheal intubation
7. Contraindications to use of local anaesthetics or regional anaesthesia placement.
8. Preoperative hoarseness of voice or voice change.
9. Any group of patients where the quality of voice is essential, Eg. singers, teachers etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in mean blood pressure (MBP)/mean arterial pressure (MAP) from pre-intubation to 1 min post intubation in the two groups |
preopeartive baseline value, pre intubation, 1 min after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) ∆Systolic BP/Diastolic BP/Mean BP pre-intubation and at 3, 5 minutes post-intubation.
2) ∆Heart rate pre-intubation and at 1, 3, 5 minutes post-intubation.
3) Effect of time taken for laryngoscopy and intubation on hemodynamic response.
4) Incidence of postoperative sore throat.
5) Any adverse event related to the procedure like coughing or aspiration. |
1, 3 and 5 min after intubation from preintubation values
Postoperative period |
|
|
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)
|
31/01/2024 |
| 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 - NO
|
|
Brief Summary
|
The study is designed to investigate the effectiveness of ultrasound-guided superior laryngeal nerve block as an adjuvant to general anaesthesia on hemodynamic response to intubation in hypertensive patients. It was hypothesized that ultrasound-guided block of bilateral internal branch of superior laryngeal nerve would reduce hemodynamic response (measured using mean blood pressure) to intubation when compared to no block group when given as an adjuvant to general anaesthesia in hypertensive patients. |