| CTRI Number |
CTRI/2021/01/030232 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
21/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comaparison of cisatracurium muscle relaxant administered via two different moethods during surgical procedures under general anaesthesia |
|
Scientific Title of Study
|
A comparative study of effect of intermittent and continuous infusion of cisatracurium in patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DHRUVIKA CHAUDHRY |
| Designation |
PG RESIDENT |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL
BABA FARID UNIVERSITY OF HEALTH SCIENCES
FARIDKOT
PUNJAB
Faridkot
PUNJAB
151203
India |
| Phone |
9876891177 |
| Fax |
|
| Email |
dhruvikachaudhry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NARESH BAGHLA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL
BABA FARID UNIVERSITY OF HEALTH SCIENCES
FARIDKOT
PUNJAB
Faridkot
PUNJAB
151203
India |
| Phone |
9814035236 |
| Fax |
|
| Email |
drbaghla@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
NARESH BAGHLA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL
BABA FARID UNIVERSITY OF HEALTH SCIENCES
FARIDKOT
PUNJAB
Faridkot
PUNJAB
151203
India |
| Phone |
|
| Fax |
|
| Email |
drbaghla@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT, PUNJAB |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of anaesthesiology, GGS Medical college and hospital,
Faridkot, Punjab |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR HARAMRITPAL KAUR |
ASSOCIATE PROFESSOR,
GGS MEDICAL COLLEGE AND HOSPITAL,FARIDKOT, PUNJAB |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DHRUVIKA CHAUDHRY |
GGS MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT, PUNJAB 151203
Faridkot
PUNJAB |
9876891177
dhruvikachaudhry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cisatracurium given by continuous infusion |
Cisatracurium muscle relaxant will be given by continuous infusion in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Continuous TOF will be monitored and when T1 will recover to 20%, continuous infusion of cisatracurium in the dose of 3 μg.kg−1.min−1 will be started. infusion rate will be regulated to maintain T1 less than 10%. Infusion will be given till starting of closure of muscle layer. |
| Comparator Agent |
Cisatracurium given by intermittent boluses. |
Cisatracurium will be given by intermittent boluses. Loading dose of 0.1mg/kg will be given during induction followed by bolus doses of 0.03mg/kg when T1 will recover to 20%. Cisatracurium will be given the last time according to operative process and neuromuscular blocking effects. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 18-65 years of either gender.
2) ASA grade I and II.
3) Patients scheduled to undergo elective laparoscopic cholecystectomy surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1) Laparoscopic cholecystectomy converted to open cholecystectomy.
2) Patients with body mass index more than 30 kg/m2.
3) Pregnant females.
4) Patients taking drugs which interfere with neuromuscular blockade before operation.
5) Patient refusal to give consent.
6) Patients with neuromuscular disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare cisatracurium administration by continuous infusion or intermittent bolus injection in regards to total dose of cisatracurium consumption |
Intraoperatively every 5 minutes till 30 minutes and every 10 minutes till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic changes and any side effects during general anaesthesia. |
intraoperatively every 5 minutes till 30 minutes and every 10 minutes till end of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/01/2021 |
| Date of Study Completion (India) |
17/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Muscle relaxants are an integral part of
administering general anaesthesia in patients. Cisatracurium is a newer non-depolarizing
skeletal muscle relaxant with an intermediate duration of action. We will be comparing effect of intermittent doses and continuous infusion of cisatracurium in patients undergoing laparoscopic cholecystectomy in regards to total dose of cisatracurium consumption. The study has 2 groups with sample size of 60 patients including both males and females of age 18-65 years and excluding patients who refuse to give consent, laparoscopic surgery converted to open cholecystectomy, pregnant patients, BMI >30, patients with neuromuscular disorder and patients taking drugs which interfere with neuromuscular blockade of the drug. |