CTRI Number |
CTRI/2023/03/050300 [Registered on: 03/03/2023] Trial Registered Prospectively |
Last Modified On: |
16/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
Effect of intraoperative magnesium sulphate in craniotomy patients |
Scientific Title of Study
|
Effect of intraoperative magnesium sulphate infusion on total anaesthetic requirement and postoperative analgesia in craniotomy patients: A prospective interventional study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Manoj Kumar Giri |
Designation |
Professor |
Affiliation |
DR RMLIMS |
Address |
Department of Anaesthesiology Administrative block
Dr RMLIMS campus
Vibhuti Khand
Gomti Nagar
Lucknow
Lucknow UTTAR PRADESH 226010 India |
Phone |
9044479649 |
Fax |
|
Email |
drmanoj.giri@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manoj Kumar Giri |
Designation |
Professor |
Affiliation |
DR RMLIMS |
Address |
Department of Anaesthesiology
Administrative block
Dr RMLIMS campus
Vibhuti Khand
Gomti Nagar
Lucknow
Lucknow UTTAR PRADESH 226010 India |
Phone |
9044479649 |
Fax |
|
Email |
drmanoj.giri@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nidhi Varma |
Designation |
Junior Resident |
Affiliation |
DR RMLIMS |
Address |
Dr RMLIMS ROOM No 601
Vibhuti khand
Gomti nagar
Lucknow
Lucknow UTTAR PRADESH 226010 India |
Phone |
9933208279 |
Fax |
|
Email |
nidhivarma2424@gmail.com |
|
Source of Monetary or Material Support
|
Dr RMLIMS Lucknow Uttar Pradesh |
|
Primary Sponsor
|
Name |
Dr Manoj Kumar Giri |
Address |
Faculty apartment
Dr.RMLIMS campus
Vibhuti Khand
Gomti Nagar
Lucknow |
Type of Sponsor |
Other [Individual] |
|
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 Manoj Kumar Giri |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
Neurosurgery ot
2nd floor
Dr.RMLIMS Lucknow UTTAR PRADESH |
9044479649
drmanoj.giri@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
DR RMLIMS LUCKNOW |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, (2) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Magnesium sulphate |
Administration of magnesium sulphate infusion in craniotomy patients after induction till dura closure |
Intervention |
nil |
In control group patients undergoing craniotomy will not be given MgSO4 |
Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
59.00 Year(s) |
Gender |
Both |
Details |
ASA Grade 1 and 2 patients
Elective craniotomies (both supratentorial and posterior fossa surgeries)
GCS 15
|
|
ExclusionCriteria |
Details |
ASA Grade III and IV
Pregnant female
Patients with neuromuscular renal cardiovascular 0r hepatic insufficiency
BMI<18.5 or > 24.9kg/m2
Allergy to the study drugs
Those on treatment with calcium channel blockers or magnesium
Patients who will be shifted on ventilator post craniotomy
Anaesthesia time more than 5 hrs preventing excessive infusion of MgSO4
Any other mental or physical illness rendering them incapable of answering pain score
Patient on any previous chronic pain medications like gabapentin or pregabalin
Trauma and emergency craniotomies |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Effect of magnesium sulphate on reduction in post operative rescue analgesic requirement and post operative pain in the study group |
start magnesium sulphate after induction till closure of dura.Post operative pain will be assessed at 1st hr 2nd hr 4th hr 6th hr 8th hr 12th hr 16th hr 20th hr and 24 hrs |
|
Secondary Outcome
|
Outcome |
TimePoints |
Effect of MgSO4 on reduction of intraop dose of Propofol and Vecuronium during surgery |
start magnesium sulphate after induction till closure of dura |
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
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)
|
15/03/2023 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
AIM : This study has to evaluate effect of MgSO4 on total anaesthetic requirement intraoperatively as well as post operative total analgesic requirement in craniotomy patients . OBJECTIVE : Primary - Comparing total post operative rescue analgesic (tramadol) requirement in patients on MgSO4 infusion during craniotomy to that of patients not on MgSO4 infusion during craniotomy . Secondary : 1. Comparing post operative VAS score in both the groups for 24 hours . 2. Comparing total dose of Propofol and Vecuronium required in the study and control group till the end of surgery .
|