| CTRI Number |
CTRI/2025/04/084125 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of blood pressure and heart rate changes using two muscle relaxant drugs for intubation of patients undergoing Laparoscopic appendicectomy. |
|
Scientific Title of Study
|
Comparison of haemodynamic changes with Rocuronium vs. Vecuronium for intubation of patients undergoing Laparoscopic appendicectomy under general anaesthesia: a double blind 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 |
Priya Gupta |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
College of medicine and Sagore Dutta Hospital, Department of Anaesthesiology, 578, Barrackpore Trunk Road, Kolkata.
Kolkata
WEST BENGAL
700058
India |
| Phone |
9123872867 |
| Fax |
|
| Email |
priya140899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya Gupta |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
College of medicine and Sagore Dutta Hospital, Department of Anaesthesiology, 578, Barrackpore Trunk Road, Kolkata.
Kolkata
WEST BENGAL
700058
India |
| Phone |
9123872867 |
| Fax |
|
| Email |
priya140899@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya Gupta |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
College of medicine and Sagore Dutta Hospital, Department of Anaesthesiology, 578, Barrackpore Trunk Road, Kolkata.
Kolkata
WEST BENGAL
700058
India |
| Phone |
9123872867 |
| Fax |
|
| Email |
priya140899@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, College of medicine and Sagore Dutta hospital, 578 Barrackpore Trunk Road , Kolkata-700058, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
College of medicine and Sagore Dutta Hospital, 578, Barrackpore Trunk Road, Kolkata- 700058, West Bengal, 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 |
| Prof DrSubrata Kumar Mandal |
College of Medicine and Sagore Dutta Hospital |
Department of anaesthesiology, OT Complex,
578, Barrackpore Trunk Road, Kolkata-700058
Kolkata
WEST BENGAL |
9433175801
drsubrata2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College of medicine and Sagore Dutta Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K389||Disease of appendix, unspecified, (2) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (3) ICD-10 Condition: K36||Other appendicitis, (4) ICD-10 Condition: K388||Other specified diseases of appendix, (5) ICD-10 Condition: K37||Unspecified appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General anaesthesia with Rocuronium |
To determine haemodynamic changes with the drug for the 1st 30 minutes after intubation and note any adverse events for 12 hours after completion of procedure. |
| Comparator Agent |
General anaesthesia with Vecuronium |
To determine haemodynamic changes with the drug for the 1st 30 minutes after intubation and note any adverse events for 12 hours after completion of procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiologists (ASA) grade I and II
2.Patients undergoing Laparoscopic appendicectomy under General anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Pregnant
2.Lactating mothers
3.Patient with hypersensitivity to any of the research drugs
4.Patients undergone clinical trial within 3 months
5.Anticipated difficult airway
6. Patients having contraindication for laparoscopic surgeries
7.Severe Systemic diseases(Hypertension, Diabetes Mellitus, Seizure Disorder,
Neurological Disorders, etc.) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare changes in the mean artrial blood pressure and heart rate using Rocuronium and Vecuronium in patients undergoing laparoscopic appendicectomy under general anaesthesia |
1.Before intubation
2.Just after intubation
3.15 minutes after intubation
4.30 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the ease of intubation between the two groups |
During intubation |
| To compare the adverse events of the two muscle relaxants used |
12 hours post-operative period |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
14/05/2025 |
| 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 - NO
|
|
Brief Summary
|
Laparoscopic surgeries are minimally invasive, less painful
and thus shorten the hospital stay. Transient self-limiting increase in heart rate and blood pressure is
common sequelae of direct laryngoscopy and intubation and are potentially hazardous. Laryngoscopy, intubation, pneumoperitoneum and
carbo-peritoneum - these are also accompanied by positional changes in Laparoscopic appendicectomy. This has
increased the challenges of maintaining haemodynamic stability for the
anaesthesiologists. So, in our study we are looking forward to identify whether
Rocuronium is a better muscle relaxant as compared to conventional Vecuronium for
the patients undergoing Laparoscopic Appendicectomy under General Anaesthesia. |