| CTRI Number |
CTRI/2024/09/073423 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Mgso4 as adjuvant to bupivacaine in spinal anesthesia in lower abdominal surgery |
|
Scientific Title of Study
|
Efficacy of Mgso4 with bupivacaine vs bupivacaine alone in spinal anesthesia in lower abdominal surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonal Sutariya |
| Designation |
Resident Doctor |
| Affiliation |
B j medical college , Ahmedabad |
| Address |
F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9638321856 |
| Fax |
|
| Email |
sonu.sutariya25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandresh Shah |
| Designation |
Assistant professor |
| Affiliation |
B j medical College |
| Address |
F3, Department of anaesthesia, civil hospital, b j medical College, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9328972082 |
| Fax |
|
| Email |
csshah298@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chandresh Shah |
| Designation |
Assistant professor |
| Affiliation |
B j medical College |
| Address |
F3, Department of anaesthesia, civil hospital, b j medical College, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9328972082 |
| Fax |
|
| Email |
csshah298@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of gujarat, B j medical College and Civil hospital , asarwa, ahmedabad 380016, Gujarat ,india |
|
|
Primary Sponsor
|
| Name |
B j medical college Ahmedabad |
| Address |
7th floor, health and family welfare department, sachivalay, Gandhinagar -382010, Gujarat, India |
| Type of Sponsor |
Government 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 sonal sutariya |
B.j. medical College and Civil hospital, Ahmedabad |
Department of anaesthesia, operation theatre,trauma centre, Civil hospital,asarwa , Ahmedabad -380016
Ahmadabad
GUJARAT |
9638321856
Sonu.sutariya25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethics committee, b j medical College and Civil hospital, Ahmedabad |
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 |
| Comparator Agent |
hyperbaric bupivacaine(0.5%) |
Hyperbaric bupivacaine (0.5%) without adjuvant total volume 3.5ml in spinal anaesthesia |
| Intervention |
hyperbaric bupivacaine(0.5%) with Mgso4 |
Mgso4(50 mg) is added to hyperbaric bupivacaine (0.5%) total volume 3.5 ml in spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II,III
Elective lower abdominal surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
ASA IV,V
Emergency surgery
Presence of primary or secondary adrenal insufficiency
Presence of valvular heart disease
Previous allergic reaction to magnesium sulfate |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study onset and duration of sensory and motor block , duration of analgesia |
Study duration of sensory and motor block and duration of analgesia in 24 hour postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative hemodynamic parameters in both groups
To compare any complication in both groups |
24 hours post operative |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
13/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Spinal Anaesthesia is preferred choice of anaesthesia in lower abdominal surgery. Hyperbaric bupivacaine is most commonly used drug for spinal anaesthesia but duration of action of bupivacaine is not enough in prolonged surgery. Post operative pain relief is major problem spinal anaesthesia using only local anaesthetics is associated with short duration of action and requires early analgesic intervention in post operative period. So this study performed to observe onset and duration of sensory and motor block , duration of analgesia and requirement of analgesic in post operative period |