| CTRI Number |
CTRI/2025/10/095969 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISION OF DEXMEDETOMIDINE AND MAGNESIUM SULPHATE AS ADJUVANTS WITH HYPERBARIC ROPIVACAINE FOR SPINAL ANAESTHESIA IN INFRAUMBILICAL SURGERIES
|
|
Scientific Title of Study
|
COMPARISION OF DEXMEDETOMIDINE AND MAGNESIUM SULPHATE AS ADJUVANTS WITH HYPERBARIC ROPIVACAINE FOR SPINAL ANAESTHESIA IN INFRAUMBILICAL SURGERIES:
A PROSPECTIVE RANDOMIZED DOUBLE- BLIND 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 DHARMISHTHABEN HASMUKHBHAI VASAVA |
| Designation |
SECOND YEAR RESIDENT ANAESTHESIOLOGY |
| Affiliation |
SIR SAYAJI RAO GAEKWAD HOSPITAL |
| Address |
ANAESTHESIOLOGY DEPARTMENT SIR SAYAJI RAO GAEKWAD HOSPITAL ANANDPURA VADODARA GUJARAT PIN CODE 390001
SIR SAYAJI RAO GAEKWAD HOSPITAL ANANDPURA VADODARA GUJARAT PIN CODE 390001
Vadodara
GUJARAT
390001
India |
| Phone |
9925580329 |
| Fax |
|
| Email |
vasavanilu64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JALPA BALAT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SIR SAYAJI RAO GAEKWAD HOSPITAL |
| Address |
ANAESTHESIOLOGY DEPARTMENT SIR SAYAJI RAO GAEKWAD HOSPITAL ANANDPURA VADODARA GUJARAT PIN CODE 390001
SIR SAYAJI RAO GAEKWAD HOSPITAL ANANDPURA VADODARA GUJARAT PIN CODE 390001
Vadodara
GUJARAT
390001
India |
| Phone |
9909967624 |
| Fax |
|
| Email |
jalpadamor53023@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JALPA BALAT |
| Designation |
Assistant Professor |
| Affiliation |
SIR SAYAJI RAO GAEKWAD HOSPITAL |
| Address |
ANAESTHESIOLOGY DEPARTMENT SIR SAYAJI RAO GAEKWAD HOSPITAL ANANDPURA VADODARA GUJARAT PIN CODE 390001
SIR SAYAJI RAO GAEKWAD HOSPITAL ANANDPURA VADODARA GUJARAT PIN CODE 390001
Vadodara
GUJARAT
390001
India |
| Phone |
9909967624 |
| Fax |
|
| Email |
jalpadamor53023@gmail.com |
|
|
Source of Monetary or Material Support
|
| SSG Hospital and government medical college Vadodara Gujarat India. pincode 390001 |
|
|
Primary Sponsor
|
| Name |
SIR SAYAJI RAO GAEKWAD HOSPITAL |
| Address |
SIR SAYAJI RAO GAEKWAD HOSPITAL ANANDPURA VADODARA GUJARAT PIN CODE 390001 |
| 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 DHARMISHTHABEN HASMUKHBHAI VASAVA |
SSG HOSPITAL |
SIR SAYAJI RAO GAEKWAD HOSPITAL ANANDPURA VADODARA GUJARAT PIN CODE 390001
Vadodara
GUJARAT |
9925580329
vasavanilu64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research Vadodara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INJECTION DEXMEDETOMIDINE 10 MICROGRAM WITH HYPERBARIC ROPIVACAINE 2.5ML |
AFTER PREANESTHETIC EVALUATION,PATIENTS MEETING THE INCLUSION CRITERIAWILL BE SELECTED.INTHE OPERATIONTHEATRE NECESSORY DRUGA AND EQUIPMENTA KEPT READY.SPINAL ANAESTHESIA WILL BE GIVEN IN L3-L4 SPACE.PATIENTS WILL BE DIVIDED IN TO TWO INJECTION HYPERBARIC ROPIVACAINE 2.5 ML WITH INJECTION DEXMEDETOMIDINE 10 MICROGRAM WILL BE GIVEN INTRATHECALLY WITHOUTBARBOTAGE,PATIENT IS IMMEDIEATELY PUT IN SUPINE POSITON WITHOUT RAISING EXTREMITIES AND MONITORING OF PARAMETERS WILL BE STARTED IMMEDIETELY.SENSORY AND MOTOR BLOCKADE REQUIREMENT OF INJECTION EPIDRINE WILL BE OBSERVED |
| Intervention |
INJECTION MAGNESIUM SULPHATE 75MG WITH INJECTION HYPERBARIC ROPIVACAINE 2.5ML |
AFTER PREANESTHETIC EVALUATION,PATIENTS MEETING THE INCLUSION CRITERIA WILL BE SELECTED.INTHE OPERATION THEATRE NECESSORY DRUGS AND EQUIPMENTA KEPT READY.SPINAL ANAESTHESIA WILL BE GIVEN IN L3-L4 SPACE.PATIENTS WILL BE DIVIDED IN TO TWO INJECTION HYPERBARIC ROPIVACAINE 2.5 ML WITH INJECTION MAGNESIUM SULPHATE 75MG WILL BE GIVEN INTRATHECALLY WITHOUT BARBOTAGE,PATIENT IS IMMEDIEATELY PUT IN SUPINE POSITON WITHOUT RAISING EXTREMITIES AND MONITORING OF PARAMETERS WILL BE STARTED IMMEDIETELY.SENSORY AND MOTOR BLOCKADE REQUIREMENT OF INJECTION EPHIDRINE WILL BE OBSERVED
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Group – 18 years to 60 years
2. ASA – I/II/III
3. Infraumbilical surgeries
4. Duration of surgery 2 to 2.5 hrs
|
|
| ExclusionCriteria |
| Details |
1.Patients Refusal
2.Patient with history of previous spine surgery
3.Heart block & ventricular dysfunction
4.Patient with spine deformity
5.Patient on anticoagulant therapy
6.Patient with local site infection
7.Patients with allergy to study drugs
8.Severe hypovolemia
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset and duration of sensory and motor blockade
|
Till 24 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Post operative analgesia if VAS score greater then and equal to 4 or on patient demand as a rescue analgesia
2 Requirement of Rescue analgesia in 24 hours
3 Hemodynamic changes like HR SBP DBP MAP SPO2
4 Complication if any if any bradycardia hypotension nausea vomiting
shivering,respiratory, depression.
|
Intraoperative and postoperative till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/11/2025 |
| 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="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
|
Comparision of Dexmedetomidine and Magnesium sulfate as adjuvants with Hyperbaric Ropivacaine for spinal anaesthesia in infraumbilical surgeries : A Prospective Randomized Double –Blind clinical study. As per the central limit theorem ,a sample size of at least 30 is often considered a good enough for reliable statistical inferences about the population. When a sample is 30 or greater ,the sampling distribution of the population distribution is not normal. so we will take 30 cases each in control and intervention group in our study. | Group RD | Inj. Hyperbaric Ropivacaine (0.75%) 2.5 ml+ Inj Dexmedetomidine 10micrograms | | Group RM | Inj. Hyperbaric Ropivacaine (0.75%) 2.5 ml+ Inj Magnesium sulphate 75mg |
Primary objectives of the study are Onset and duration of sensory and motor blockade Secondary objectives of the study are Post operative analgesia if VAS score greater then and equal to 4 or on patient demand as a rescue analgesia Requirement of Rescue analgesia in 24 hours Hemodynamic changes like HR SBP DBP MAP SPO2 Complication if any if any bradycardia hypotension nausea vomiting shivering,respiratory depression
As there is limited study available regarding efficacy of hyperbaric ropivacaine with dexmedetomidine and magnesium sulphate as an adjuvant, so we decide to do comparision of hyperbaric ropivacaine with dexmedetomidine and magnesium sulphate in infraumbilical surgeries with primary aims to onset and duration of sensory and motor blockage and secondary aims to post operative analgesia, requirement of rescue analgesia , hemodynamic stability and complication if any |