| CTRI Number |
CTRI/2021/02/031434 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
09/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of magnesium sulphate on total amount of muscle relaxant required to conduct deep and moderate neuromuscular block surgeries and the effect of magnesium sulphate on total amount of fentanyl required to releive postoperative pain after these surgeries. |
|
Scientific Title of Study
|
Impact of pretreatment with magnesium sulphate on depth of neuromuscular block and postoperative pain in 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 |
ANUREET KAUR |
| Designation |
PG JUNIOR RESIDENT FIRST YEAR Anaesthesiology |
| Affiliation |
GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT.
FARIDKOT
PUNJAB
151203
India
DEPARTMENT OF ANAESTHESIOLOGY
GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT.
FARIDKOT
PUNJAB
151203
INDIA
Faridkot
PUNJAB
151203
India |
| Phone |
9478358947 |
| Fax |
|
| Email |
bajwaanureet74.akb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANUREET KAUR |
| Designation |
PG JUNIOR RESIDENT FIRST YEAR Anaesthesiology |
| Affiliation |
GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT.
FARIDKOT
PUNJAB
151203
India
DEPARTMENT OF ANAESTHESIOLOGY
GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT.
FARIDKOT
PUNJAB
151203
INDIA
PUNJAB
151203
India |
| Phone |
9478358947 |
| Fax |
|
| Email |
bajwaanureet74.akb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SEEMA JINDAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT
PUNJAB
151203
DEPARTMENT OF ANAESTHESIOLOGY
GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT
PUNJAB
151203
Faridkot
PUNJAB
151203
India |
| Phone |
9646050485 |
| Fax |
|
| Email |
jindalseema77@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT, PUNJAB. 151203 |
|
|
Primary Sponsor
|
| Name |
ANUREET KAUR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT, PUNJAB |
| Type of Sponsor |
Other [guide has ensured all the facilities for the study are available in the institution] |
|
|
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 |
| Anureet Kaur |
GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT, PUNJAB |
DEPARTMENT OF ANAESTHESIA, SECOND FLOOR , MAIN OPERATION THEATRE COMPLEX, GGS MEDICAL COLLEGE AND HOSPITAL, FARIDKOT, PUNJAB
Faridkot
PUNJAB |
9478358947
bajwaanureet74.akb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thesis and Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cisatracurium |
Deep neuromuscular blockade with magnesium - Will receive 100 ml normal saline over 10 minutes as intravenous infusion before induction. Then these patients will receive bolus of cisatracurium 0.2 mg/kg two minutes after intubation followed by continous infusion of cisatracurium to maintain PTC of 1-2. |
| Intervention |
Magnesium Sulphate |
Deep neuromuscular blockade with magnesium - Will receive magnesium sulphate 30 mg/kg in 100 ml normal saline over 10 minutes as intravenous infusion before induction. Then these patients will receive bolus of cisatracurium 0.2 mg/kg two minutes after intubation followed by continous infusion of cisatracurium to maintain PTC of 1-2. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA grade 1,2,3
2)Patients aged between 18 to 60 years
3)BMI <35 Kg/m2
4)Patients scheduled for laproscopic cholecystectomy under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
1)Patient refusal to give consent
2)Patients with known hypersensitivity to magnesium and cis Atracurium
3)Pregnant patients
4)Patients with history of abdominal surgery
5)Patients with major organ dysfunction
6)Patients using any hypnotics or analgesic
7)Patients having neuromuscular disease that may interfere with neuromuscular function
8)Patients receiving medications known to influence neuromuscular function(eg. calcium channel blockers, phenytoin and aminoglycosides) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate and compare total cisatracurium consumption in deep and moderate neuromuscular blockade groups with and without magnesium sulphate |
After intubation of patient, at 5 minutes , 10 minutes , 15 minutes , 20 minutes , 25 minutes, 30 minutes , 35 minutes , 40 minutes , 2 hours, 6 hours, 12 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate Minimum effective analgesic dose of fentanyl in post anaesthesi care unit, mean VAS score at rest, on movement and on wound compression |
2 hr, 6 hr, 12 hr after surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
25/02/2021 |
| 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="1"
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
|
A total of 80 patients will be divided into 4 groups A, B, C and D. Magnesium pretreatment will be given in groups A and C i.e. Deep neuromuscular blockade group with magnesium and Moderate neuromuscular blockade witj magnesium . Control groups are group B and group D i.e. Deep neuromuscular blockade with control and Moderate neuromuscular block with control. Deep neuromuscular block will be given in groups A and B and moderate block will be given in groups C and D. |