| CTRI Number |
CTRI/2025/11/097003 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of intrathecal bupivacaine with dexmedetomidine versus intrathecal levobupivacaine with dexmedetomidine for lower limb and lower abdominal surgeries |
|
Scientific Title of Study
|
Comparison of intrathecal bupivacaine versus intrathecal levobupivacaine with dexmedetomidine as an adjuvant for lower limb and lower abdominal surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Loka Priya |
| Designation |
Junior resident |
| Affiliation |
sapthagiri institute of medical sciences and research center |
| Address |
Department of Anaesthesia
ground floor ot complex
sapthagiri institute of medical sciences and research center
chikkasandra, hesaraghatta main road
Bangalore
India
Department of anaesthesia
ground floor ot complex sapthagiri institute of medical sciences and research center
chikkasandra, hesaraghatta main road
Bangalore
India
Bangalore
KARNATAKA
560090
India |
| Phone |
9482422599 |
| Fax |
|
| Email |
lokapriya.loku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anand Tippanna Talikoti |
| Designation |
Professor |
| Affiliation |
sapthagiri institute of medical sciences and research center |
| Address |
Department of Anaesthesia
ground floor ot complex
sapthagiri institute of medical sciences and research center
chikkasandra, hesaraghatta main road
Bangalore
Department of Anaesthesia
ground floor ot complex
sapthagiri institute of medical sciences and research center
chikkasandra, hesaraghatta main road
Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
9986093837 |
| Fax |
|
| Email |
drttanand@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anand Tippanna Talikoti |
| Designation |
Professor |
| Affiliation |
sapthagiri institute of medical sciences and research center |
| Address |
Department of Anaesthesia
ground floor ot complex
sapthagiri institute of medical sciences and research center
chikkasandra, hesaraghatta main road
Bangalore
Department of Anaesthesia
ground floor ot complex
sapthagiri institute of medical sciences and research center
chikkasandra, hesaraghatta main road
Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
9986093837 |
| Fax |
|
| Email |
drttanand@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ground floor ot complex
sapthagiri institute of medical sciences and research center
chikkasandra, hesaraghatta main road
Bangalore
560090 |
|
|
Primary Sponsor
|
| Name |
sapthagiri institute of medical science and research center |
| Address |
ground floor ot complex
sapthagiri institute of medical sciences and research center
chikkasandra, hesaraghatta main road
Bangalore
560090 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 V Loka Priya |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of
Anaesthesiology
Ground Floor OT
Complex, #15
Hesarghatta Main
Road, Chikkabanavara
Bangalore
KARNATAKA
560090
Bangalore
KARNATAKA |
9482422599
lokapriya.loku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of medical science and research center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients willing to participate in study and provide informed consent.
ASA physical status I and II.
Age between 18 to 60 years.
Patient posted for surgery under spinal anaesthesia. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3ml levobupivacaine + dexmedetomidine(5mcg) will be given to group LD and 3ml of levobupivacaine + dexmedetomidine(5mcg) will be given to group BD. |
after giving spinal anaesthesia the onset and duration of sensory and motor block and hemodynamic parameters will be measured immediately after the block,5,10,15,20,25,30 and 60 minutes after spinal block, at the end of procedure every 60minutes in recovery room. |
| Comparator Agent |
comparison of inthrathecal bupivacaine versus intathecal levobupivacaine with dexmedetomidine as an adjuvant |
out of 62 subjects 31 will receive 3ml of bupivacaine + dexmedetomidine(5mcg) and the other 31 will receive 3ml of levobupivacaine + dexmedetomidine(5mcg) as per group allocation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient willing to participate in study and provide informed consent.
ASA physical status 1 and 2.
age between 18 to 60 years
patient posted for surgery under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
participants with history of allergy to study drugs.
participants with bleeding disorders, uncontrolled diabetic mellitus, cardiovascular, renal and liver disorders.
local site infection, peripheral vascular disease.
patients with pyschiatric disorder and on antipsychotic medications.
pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare intrathecal bupivacaine and dexmedetomidine versus intrathecal levobupivacaine and dexmedetomidine in terms of onset and duration of sensory and motor block |
dermatomes levels will be
tested every 2 min and sensory level is noted. Time to two segment sensory regression
will be recorded. The motor dermatome level will be assessed using Modified
Bromage scale. The time to reach Bromage scale 3 before surgery and Bromage 0 in
post anaesthesia care unit (PACU) will be recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare two drugs in terms of duration of analgesia hemodynamic parameter and any adverse effects |
immediately after
block, during the operation at 5, 10, 15,20,25, 30, and 60 min after spinal block, at the
end of the procedure and every 60 min in the recovery room. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/11/2025 |
| 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="6"
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
|
patient fulfilling the inclusion criteria will be assessed spinal anesthesia will be given the mentioned parameters like onset and duration of sensory motor block duration of analgesia hemodynamic parameter and any adverse effects will be assessed. dermatomes levels will be tested every 2 min and sensory level is noted. Time to two segment sensory regression will be recorded. The motor dermatome level will be assessed using Modified Bromage scale. The time to reach Bromage scale 3 before surgery and Bromage 0 in post anaesthesia care unit (PACU) will be recorded On achieving adequate sensory blockade level surgery will be allowed.Hemodynamic monitoring including SBP and DBP mean arterial pressure,heart rate and peripheral oxygen saturation level will be recorded intra and postoperation as follow at the baseline values (before block)immediately after block during the operation at 5, 10, 15,20,25, 30, and 60 min after spinal block, at the end of the procedure and every 60 min in the recovery room. |