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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 appearanceMajor 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.



 
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