| 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
|
|
|
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
|
|
|
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 |
|
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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. |