| CTRI Number |
CTRI/2025/08/093219 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Method of giving spinal anesthesia ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparaing bolus and fractionally divide doses of spinal anaesthesia in high risk patients undergoing lower limb surgeries. |
|
Scientific Title of Study
|
Comparative study of hemodynamic effects of bolus and fractionated doses of spinal anesthesia in high risk patients undergoing lower limb surgeries A Randomised controlled double blind prospective 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 |
Spandana gs |
| Designation |
Post graduate MD anesthesia |
| Affiliation |
SDM college of medical science and hospital |
| Address |
Department of anesthesia SDM college of medical science and hospital manjushree Nagar sattur dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8970502636 |
| Fax |
|
| Email |
mhkavitha532@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shriranga Torgal |
| Designation |
Professor and head ,department of anesthesia |
| Affiliation |
SDM college of medical science and hospital |
| Address |
Department of anesthesiology,SDMCMSH manjushree Nagar, sattur dharwad 570009 sdm college of medical science and hospital dharwad
Dharwad
KARNATAKA
570009
India |
| Phone |
9845153650 |
| Fax |
|
| Email |
Shrirangtorgal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shriranga Torgal |
| Designation |
Professor and head ,department of anesthesia |
| Affiliation |
SDM college of medical science and hospital |
| Address |
Department of anesthesiology,SDMCMSH manjushree Nagar, sattur dharwad 570009 sdm college of medical science and hospital dharwad
Dharwad
KARNATAKA
570009
India |
| Phone |
9845153650 |
| Fax |
|
| Email |
Shrirangatorgal@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical science and hospital manjushree Nagar
sattur dharwad 580009 |
|
|
Primary Sponsor
|
| Name |
Sdm college of medical science |
| Address |
Sdm college of medical sciences and hospital manjushree nagar sattur dharwad 580009 |
| Type of Sponsor |
Private 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 |
| Spandana gs |
Sdm college of medical science and hospital |
Department of anesthesia 2nd floor SDM college of medical college and hospital manjushree Nagar sattur dharwad 580009
Dharwad
KARNATAKA |
8970502636
mhkavitha532@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM college of medical science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional spinal anaesthesia |
Patient informed consent taken. Patient of ASA3 and 4 groups undergoing lower limb surgeries are randomly allocated into 2 groups by computer based allocation. 2 groups
Group B- Bolus dose of bupivacaine heavy 0.5% 0.2mg/kg with 0.5mcg/kg buprinorphine according to ideal body weight
Group F-- fractionated dose of bupivacaine heavy 0.5% 0.2mg/kg with 0.5mcg/kg buprinorphine according to ideal body weight 2/3rd followed by 1/3rd dose 60 seconds apart.
Blood pressure and time of achieving T10 sensory level and bromage 4 is noted and duration of time of regression of sensory level by 2 dermatomes is noted and bromage 0 is noted. |
| Comparator Agent |
Fractional spinal anaesthesia is compared with bolus spinal anaesthesia for hemodynamic stability |
Patient informed consent taken. Patient of ASA3 and 4 groups undergoing lower limb surgeries are randomly allocated into 2 groups by computer based allocation. 2 groups
Group B- Bolus dose of bupivacaine heavy 0.5% 0.2mg/kg with 0.5mcg/kg buprinorphine according to ideal body weight
Group F-- fractionated dose of bupivacaine heavy 0.5% 0.2mg/kg with 0.5mcg/kg buprinorphine according to ideal body weight 2/3rd followed by 1/3rd dose 60 seconds apart.
Blood pressure and time of achieving T10 sensory level and bromage 4 is noted and total duration is upto time of regression of sensory level by 2 dermatomes is noted and bromage 0 is noted. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA 3 And ASA 4 groups
Patients undergoing lower limb surgery |
|
| ExclusionCriteria |
| Details |
Patients not belonging to ASA 3 And ASA 4 groups
Patients not undergoing lower limb surgery
Patients less than 40 years of age |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the study we anticipate a clear cut hemodynamic stability in high risk patients till 24 hours |
At the end of the study we anticipate a clear cut hemodynamic stability in high risk patients till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased duration of sensory & motor blockage till twentyfour hours |
Increased duration of sensory & motor blockage till 24 hours |
|
|
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)
|
10/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/09/2025 |
| 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
|
Ethical committee approval taken. Patient informed consent taken. Patient of ASA3 and 4 groups undergoing lower limb surgeries are randomly allocated into 2 groups by computer based allocation. 2 groups Group B- Bolus dose of bupivacaine heavy 0.5% 0.2mg/kg with 0.5mcg/kg buprinorphine according to ideal body weight Group F-- fractionated dose of bupivacaine heavy 0.5% 0.2mg/kg with 0.5mcg/kg buprinorphine according to ideal body weight 2/3rd followed by 1/3rd dose 60 seconds apart. Blood pressure and time of achieving T10 sensory level and bromage 4 is noted and time of regression of sensory level by 2 dermatomes is noted and bromage 0 is noted. |