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CTRI Number  CTRI/2024/11/076818 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparison of atracurium and cisatracurium on heart rate and blood pressure changes in patients undergoing laparoscopic surgeries. 
Scientific Title of Study   A comparative study of efficacy of atracurium and cisatracurium for hemodynamic stability in patients undergoing laparoscopic surgeries  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshada 
Designation  Junior Resident 
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL, AURANGABAD 
Address  Department of Anaesthesia MGM Medical college and hospital N6 CIDCO Aurangabad
OT complex Department of Anaesthesia MGM Medical college and hospital N6 CIDCO Auranganad
Aurangabad
MAHARASHTRA
431001
India 
Phone  8624026066  
Fax    
Email  gondhaliharshada1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SANHITA KULKARNI 
Designation  PROFESSOR  
Affiliation  Mgm Medical college and hospital Aurangabad 
Address  Department of Anaesthesia MGM Medical college and hospital N6 CIDCO AURANGABAD
Department of Anaesthesia MGM Medical college and hospital N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
431001
India 
Phone  9881300645  
Fax    
Email  drsanhitakulkarni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Harshada 
Designation  Junior Resident 
Affiliation  Mgm Medical colleg and hospital 
Address  Mgm, Medical college and hospital N6 cidco, Aurangabad
N6 cidco, Aurangabad
Aurangabad
MAHARASHTRA
431001
India 
Phone  8624026066  
Fax    
Email  gondhaliharshada1@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Missions Medical College and Hospital N6 Cidco Aurangabad 431005 Maharashtra INDIA 
 
Primary Sponsor  
Name  MGM Medical College and Hospital Aurangabad 
Address  MGM Medical College and Hospital N6 CIDCO Aurangabad Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad Aurangabad MAHARASHTRA 431003 
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 Sanhita Kulkarni  Operation theatre complex MGM Medical college and hospital   OT NO 4 AND 5 (SURGERY OT) OT COMPLEX MAHATMA GANDHI MISSIONS MEDICAL COLLEGE AND HOSPITAL Aurangabad MAHARASHTRA
Aurangabad
MAHARASHTRA 
9881300645

drsanhitakulkarni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Ethics Comittee For Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (3) ICD-10 Condition: K92||Other diseases of digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cisatracurium   Patients will be given Cisatracurium with initial dose of 0.15 mg/kg and maintainance dose of 0.03mg/kg. Heamodynamic Parameters will be monitored every 10 minutes till the end of surgery (Maximum 3 hours) 
Comparator Agent  Atracurium   Patients will be given Atracurium with initial dose of 0.5 mg/kg and maintainance dose of 0.1mg/kg. Heamodynamic Parameters will be monitored every 10 minutes till end of surgery (Maximum 3 hours) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA GRADE 1 and 2
Patients undergoing elective laparoscopic surgeries  
 
ExclusionCriteria 
Details  Patients with known hypersensitivity to neuromuscular blocking agents, BMI more than 30, patiets on beta blockers,patients on antipsychotics 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the hemodynamic parameters between cisatracurium and atracurium  1 Baseline after the patient is shifted to Ot table
2 Immediately after administering NMBA
3 Immediately after Intubation
4 5 minutes after Intubation
5 Just before creation of pneumoperitoneum
6 Every 10 minutes till the completion of surgery
7 After desufflation
8 At extubation
 
 
Secondary Outcome  
Outcome  TimePoints 
To observe requirement of vasoactive agents inintraoperative period, complications like erythema, hypotension,bronchospam between the two groups  Baseline after the patient is shifted to Ot table
Immediately after administering NMBA
Immediately after Intubation
5 minutes after Intubation
Just before creation of pneumoperitoneum
Every 10 minutes till completion of surgery
At the end of surgery
At deflation
At extubation
 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   Phase 3 
Date of First Enrollment (India)   01/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 done very commonly nowadays in every part of the world. They have many advantages compared to open procedures like less surgical trauma, less intraoperative and postoperative pain which would result in early ambulation and discharge, thus reducing duration and cost of hospital stay.However, Surgical stress responses during laparoscopic surgeries may be as strong as in open surgeries due to creation of pneumoperitoneum by carbon dioxide.It may lead to alteration in acid base balance, cardiovascular and pulmonary physiology. The introduction of nondepolarizing neuromuscular blocking agents has helped overcome most of these adverse effects making the administration of neuromuscular blockade comparatively safer. Neuromuscular blocking drugs interrupt transmission of nerve impulses at neuromuscular junction thus aid endotracheal intubation, mechanical ventilation, decrease anaesthetic requirement, prevent patient movement, facilitate surgery and decrease oxygen consumption by reducing the work of breathing.(4,5) Vecuronium and Atracurium are commonly used NMBAs in General Anaesthesia.Atracurium is preferred in patients with renal failure and does not affect intracranial or intraocular pressure. However, it has the potential to cause histamine release. Cisatracurium, a purified stereoisomer of atracurium, is similar to it in almost all aspects but is not associated with histamine release in humans. So it can be helpful in maintaining hemodynamic stability.  So we decided to compare hemodynamic characteristics of atracurium and cisatracurium. Apart from neuromuscular blockers, other medications like alpha2 agonists- Dexmeditomidine,  nitroglycerine  a venodilator, beta blockers and opioids are used to provide hemodynamic stability during pneumoperitoneum created for laparoscopic surgeries.  There are some previous studies which have compared Atracurium and Cisatrcurium for maintaining hemodynamic stability in general anaesthesia other than laparoscopic surgeries. Our primary outcome is to compare hemodynamic characteristics and secondary outcome is to observe requirement of vasoactive agents (vasopressors and vasodilators) in intraoperative period, complications like erythema, hypotension, bronchospasm between the two groups.

 
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