| CTRI Number |
CTRI/2020/08/027400 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
25/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effects of two drugs (magnesium sulphate and nalbuphine) given along with bupivacaine for spinal anaesthesia in patients undergoing lower limb and lower abdominal surgeries . |
|
Scientific Title of Study
|
A clinical study of comparison of intrathecal magnesium sulphate (MgSO4) and intrathecal nalbuphine with 0.5% hyperbaric bupivacaine in lower limb and lower abdominal surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavana |
| Designation |
Post graduate |
| Affiliation |
Kempegowda institute of medical sciences and research hospital |
| Address |
Department of Anesthesiology,
Kempegowda Institute of Medical Sciences and research hospital, V V Puram , K R Road
Bangalore
KARNATAKA
560004
India |
| Phone |
9535755274 |
| Fax |
|
| Email |
madhurulesu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G M Sreeraghu |
| Designation |
Professor |
| Affiliation |
Kempegowda institute of medical sciences and research hospital |
| Address |
Department of Anesthesiology,
Kempegowda Institute of Medical Sciences and research hospital, V V Puram , K R Road
Bangalore
KARNATAKA
560004
India |
| Phone |
8310285860 |
| Fax |
|
| Email |
aimsraghu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana |
| Designation |
Post graduate |
| Affiliation |
Kempegowda institute of medical sciences and research hospital |
| Address |
Department of Anesthesiology,
Kempegowda Institute of Medical Sciences and research hospital, V V Puram , K R Road
Bangalore
KARNATAKA
560004
India |
| Phone |
9535755274 |
| Fax |
|
| Email |
madhurulesu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Bhavana(self)
Department of Anaesthesia ,KIMS Bangalore , KIMS resident quartes ,Room 308 . |
|
|
Primary Sponsor
|
| Name |
Dr Bhavana |
| Address |
Post graduate, Department of Anesthesiology, Kempegowda institute of medical science,
V V Puram , K R Road , Bangalore |
| Type of Sponsor |
Other [] |
|
|
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 Bhavana |
Kempegowda institute of medical sciences |
Kempegowda institute of medical sciences and research hospital , V V Puram,K R Road
Bangalore
KARNATAKA |
9535755274
madhurulesu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: K45||Other abdominal hernia, (3) ICD-10 Condition: K35-K38||Diseases of appendix, (4) ICD-10 Condition: N30-N39||Other diseases of the urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of intrathecal magnesium sulphate and intrathecal nalbuphine with 0.5% hyperbaric bupivacaine in lower limb and lower abdominal surgeries. |
Comparison of intrathecal adjuvants like magnesium sulphate and nalbuphine (opiod) for spinal anaesthesia with hyperbaric bupivacaine 0.5% in view to intensify and increase the duration of sensory blockade thus prolonging the duration of post operative analgesia in lower limb and lower abdominal surgeries. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2
Elective lower limb and lower abdominal surgeries
|
|
| ExclusionCriteria |
| Details |
Patients posted for emergencies.
Patients allergic to local anaesthetics.
Patients with severe cardiovascular , renal , respiratory and endocrinal disorders.
Patients with coagulation disorders and local sepsis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of intrathecal adjuvants like magnesium sulphate and nalbuphine (opiod) for spinal anaesthesia with hyperbaric bupivacaine 0.5% in view to intensify and increase the duration of sensory blockade thus prolonging the duration of post operative analgesia in lower limb and lower abdominal surgeries. |
From the time patient is shifted to operation theatre upto 24 hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
28/08/2020 |
| 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
|
Comparison of intrathecal adjuvants like magnesium suphate and nalbuphine (opiod) for spinal anaesthesia with hyperbaric bupivacaine 0.5% ,in view to intensify and increase the duration of sensory blockade, thus prolonging the duration of post operative analgesia in lower limb and lower abdominal surgeries. |