| CTRI Number |
CTRI/2025/09/094977 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison Of Intravenous And Intrathecal Magnesium Sulphate with Spinal anaesthesia in patients undergoing lower abdominal elective surgery to study onset and duration of numbness,pain relief and stability of blood pressure and heart rate. |
|
Scientific Title of Study
|
Comparative analysis of intrathecal and intravenous infusion of Magnesium Sulphate as adjuvant to spinal anesthesia versus spinal anesthesia with hyperbaric 0.5 percent Bupivacaine in lower abdominal elective surgeries:A prospective randomized double blinded clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kowsalya P |
| Designation |
Post-Graduate Junior Resident |
| Affiliation |
AIIMS,Raipur |
| Address |
Department of Anaesthesiology,AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
6380211096 |
| Fax |
|
| Email |
kowsi1181@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Rampal Singh |
| Designation |
Additional Proffessor |
| Affiliation |
AIIMS,Raipur |
| Address |
Department of Anaesthesiology,AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9457086753 |
| Fax |
|
| Email |
drrampalsingh@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Rampal Singh |
| Designation |
Additional Proffessor |
| Affiliation |
AIIMS,Raipur |
| Address |
Department of Anaesthesiology,AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9457086753 |
| Fax |
|
| Email |
drrampalsingh@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| ALL India institute of medical sciences ,Tatibandh,GE Road,Raipur,Chattisgarh 492099 INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 kowsalya P |
AIIMS RAIPUR |
Department of Anesthesiology, General surgery OT, Gynaecology OT, Urology OT AIIMS RAIPUR
Raipur
CHHATTISGARH |
6380597476
kowsi1181@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
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 |
Spinal Anesthesia ( Control group) |
Hyperbaric Bupivacaine 0.5 percentage 15 mg. |
| Intervention |
Spinal Anesthesia With Intrathecal Magnesium Sulphate |
80 mg Intrathecal Magnesium Sulphate 50 percentage (0.8 ml) plus 15 mg (3 ml) of 0.5 percentage hyperbaric Bupivacaine. |
| Intervention |
Spinal Anesthesia With Intravenous Magnesium Sulphate |
200 mg Of Loading Dose Of Intravenous Magnesium Sulphate Over 10 Mins Followed By Continuous Infusion Of 500 mg Magnesium Sulphate (25 mg /ml) at the rate of 20 ml/hour till end of surgery plus 15 mg(3 ml) of 0.5 percentage hyperbaric Bupivacaine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged 18- 50 years
2) Study include both male and female
3) All lower limb abdominal surgeries under Spinal Anesthesia
4) Signed informed consent given by legally authorised representative
5) ASA Grade I and II |
|
| ExclusionCriteria |
| Details |
1) Patient refusal for consent
2) Allergy to the drug
3) Patients with hypertension
4) Recent history of use of other sedatives and anxiolytics
5) Patients with history of muscle weakness and respiratory depression
6) History of spine surgeries in past, history associated with spina bifida, meningocele and meningomyelocele |
|
|
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 |
| Onset and duration of sensory and motor blockade following spinal anaesthesia |
Assessed intraoperatively at 2 mins intervals until complete block and postoperatively until regression of sensory blockade (up to 6 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters(heart rate,systolic , diastolic,mean arterial pressure, oxygen saturation) |
Measured at baseline, every 5 minutes intraoperatively for the first 30 minutes, then every 15 minutes until the end of surgery, & postoperatively at 30 min, 1 hr, 2 hr, 4 hr, & 6 hr. |
| Duration of postoperative analgesia (time from intrathecal injection to first rescue analgesic request) |
Assessed postoperatively until 24 hours. |
| Adverse effects(hypotension, bradycardia, nausea, vomiting, shivering, pruritus, respiratory depression, neurological deficits) |
Monitored intraoperatively & postoperatively for 24 hours. |
| Sedation(assessed using Ramsay sedation score) |
Intraoperatively every 15 minutes & postoperatively at 30 min, 1 hr, 2 hr, & 4 hr. |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
30/09/2025 |
| 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
|
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 the most common technique for lower abdominal surgeries as it provides rapid onset and avoids complications of general anaesthesia. However, when used with bupivacaine alone, its effect is often short-lived, requiring additional analgesics. Magnesium sulphate, through NMDA receptor antagonism and calcium channel regulation, has been shown to enhance analgesia and prolong the duration of spinal block.This prospective randomized double-blind study will compare three groups: spinal anaesthesia with bupivacaine alone, spinal anaesthesia with intravenous magnesium sulphate, and spinal anaesthesia with intrathecal magnesium sulphate. The study will evaluate onset and duration of sensory and motor block, quality of postoperative analgesia, sedation, hemodynamic stability, need for rescue analgesia, and adverse effects. Results may guide safer and more effective use of magnesium sulphate as an adjuvant to spinal anaesthesia in lower abdominal elective surgeries.
|