CTRI Number |
CTRI/2022/01/039588 [Registered on: 20/01/2022] Trial Registered Prospectively |
Last Modified On: |
19/01/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparing the Hemodynamic changes and intubating conditions between vecuronium and rocuronium in patients posted for laparoscopic cholecystectomy under general anaesthesia |
Scientific Title of Study
|
Comparison of Hemodynamic changes in patients undergoing Laparoscopic Cholecystectomy using Rocuronium and Vecuronium for intubation and maintenance under General Anesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Nikhita Juneja |
Designation |
Resident Doctor |
Affiliation |
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP |
Address |
Department of Anaesthesia,
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP
Moradabad UTTAR PRADESH 244001 India |
Phone |
9582574454 |
Fax |
|
Email |
junejanikhita@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nikhita Juneja |
Designation |
Resident Doctor |
Affiliation |
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP |
Address |
Department of Anaesthesia,
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP
UTTAR PRADESH 244001 India |
Phone |
9582574454 |
Fax |
|
Email |
junejanikhita@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr GS Jheetay |
Designation |
Professor and HOD |
Affiliation |
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP |
Address |
Department of Anaesthesia,
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP
Moradabad UTTAR PRADESH 244001 India |
Phone |
8394899649 |
Fax |
|
Email |
drgurdeep.medical@tmu.ac.in |
|
Source of Monetary or Material Support
|
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP |
|
Primary Sponsor
|
Name |
Teerthanker Mahaveer Medical College and Research Centre Moradabad UP |
Address |
Department of Anesthesia,
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP |
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 |
Dr Nikhita Juneja |
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP |
Department of Anaesthesia,
Teerthanker Mahaveer Medical College and Research Centre, Moradabad, UP Moradabad UTTAR PRADESH |
9582574454
junejanikhita@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Rocuronium - 0.6mg/kg iv |
Assessing intubation and hemodynamic conditions in patients undergoing laparoscopic cholecystectomy under general anesthesia |
Comparator Agent |
Vecuronium - 0.1mg/kg iv as loading dose |
Assessing intubation and hemodynamic conditions in patients undergoing laparoscopic cholecystectomy under general anesthesia |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
American Society of Anesthesiologists (ASA) grade I and II scheduled for surgery under general anesthesia.
Patients with BMI of 18.5-22.9 kg/m2 |
|
ExclusionCriteria |
Details |
Patients undergoing surgery with moderate to severe blood loss.
Patients who are allergic to pre-treatment or study drugs.
Patients with an anticipated difficult airway intubation.
Systemic disorders like cardiovascular , pulmonarv, hepatorenal, metabolic diseases. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To note the ease of intubation and any hemodynamic changes with respect to heart rate, blood pressure, MAP. |
After muscle relaxant, before intubation, 1 and 5 minute after intubation, before skin incision, 1 minute after skin incision,before carboperitoneum, 1 minute after carboperitoneum, 1 , 5, 10, 15, and 20 minutes after giving the drug, before extubation and 1minute and 5 minute after extubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
To look for any complications such as arrhythmias, ischemic changes or hypotension |
at every 5 mins after induction and every 5 mins post extubation for upto 30 mins |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
25/01/2022 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Laparoscopic Cholecystectomy is a gold standard
procedure for management of gall bladder stones and is usually performed under
general anaesthesia. The procedure offers several advantages over open
technique like reduction of stress response of surgery, decrease in
post-operative pain, decrease chances of wound infection and faster recovery
with good cosmetic appearance. Major disadvantages are due to physiological effects
of insufflation of CO2 in the abdomen. Neuromuscular blocking agents are useful in performing endotracheal intubation and
providing surgical relaxation. The onset time, duration of muscle relaxation
and type of surgery are major factors that determine the choice of muscle
relaxant to be used for the endotracheal intubation and surgical relaxation. Vecuronium
was the first non-depolarizing neuromuscular blocking agent with an
intermediate duration of action to be introduced into clinical practice. With both
a shorter duration of action and minimum hemodynamic side effects, it set
a standard against which all subsequent neuromuscular blocking agents were
compared. Rocuronium,
a non depolarising muscle relaxant, was first introduced and marketed in the United
States. It is known for its rapid onset and intermediate duration of action. Added advantage of Rocuronium is the rapid
onset and it is excreted unchanged in urine, hence eliminating the side effects
caused by the metabolites. AIM: Comparison of hemodynamic changes in patients
undergoing Laparoscopic Cholecystectomy
using Rocuronium and Vecuronium for intubation and maintenance under general
anaesthesia.
OBJECTIVES:
1.To
measure intubating condition
2.To
measure hemodynamic changes during intubation
3.To
measure hemodynamic changes during maintenance of general anaesthesia.
4.To
record complications, if any. The study will be conducted after obtaining clearance from the Institutional Ethical Committee and written informed consent from the patients. patients will be explained about the drugs being used in the in their own language and will also be explained that they can belong to either of the two groups. patients will be randomly divided in two groups by "chit and box" method. Control group will be given injection vecuronium 0.1mg/kg and study group will be given injection rocuronium 0.6mg/kg. Intubating
conditions will be graded and assessed according to scoring of endotracheal
intubating conditions by Cooper et al. Hemodynamic parameters : Heart rate,
Blood Pressure, MAP and SPO2 will be recorded timely. Statistical
analysis will be done using appropriate test.
|