| CTRI Number |
CTRI/2024/05/067120 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between
hyperbaric levobupivacaine and
bupivacaine. |
|
Scientific Title of Study
|
Comparative effect of intrathecal hyperbaric levobupivacaine versus bupivacaine with and without midazolam as adjuvant in lower limb surgery |
| 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 AP singh |
| Designation |
professor |
| Affiliation |
institute of medical sciences |
| Address |
Department of anaesthesiology
IMS, BHU
varanasi
BHU, varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09839412975 |
| Fax |
|
| Email |
bhuapsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumita KUmari |
| Designation |
Assistant Professor |
| Affiliation |
institute of medical science |
| Address |
Department of Anesthesiology
Institute of medical science
BHU, Varanasi
Institute of Medical Sciences,
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08765514029 |
| Fax |
|
| Email |
drsumita.1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumita KUmari |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Anesthesiology
Institute of medical science
BHU, Varanasi
Institute of medical Sciences,
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08765514029 |
| Fax |
|
| Email |
drsumita.1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of medical sciences , Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Institute of medical Sciences Banaras Hindu University |
| Address |
Varanasi,221005 |
| 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 Kavita Tamta |
Banaras Hindu University |
orthopedic elective and emergency Operation theatre, Surgery operation theatre, institute of medical Sciences
Varanasi
UTTAR PRADESH |
7760296223
93tamtakavita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
| Intervention |
Spinal anaesthesia |
Drug for spinal anaesthesia will be hyperbaric Levo bupivacaine +/- midazolam for duration of 6 months dosage.3 ml bupivacaine with 1mg , midazolam as adjuvant. It is given intrathecally at the beginning of the surgery, The start day for trial is 26/5/24 |
| Comparator Agent |
Spinal anaesthesia |
Drug will be hyperbaric bupivacaine +/- midazolam for 6 months. 3ml of hyperbaric bupivacaine given intrathecally with 1 mg midazolam as adjuvant. It is given at the beginning of surgery for subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
patient belonging to american society of anesthesiologist grade 1 and grade2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters |
0 to 360 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Characteristic of sensory and motor block |
0 to 360 minutes |
| To check any adverse effect |
0 to 360 minutes |
| Sedation |
0 to 360 minutes |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/05/2024 |
| 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 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
|
it is triple blinded interventional comparative study of levobupivacaine and bupivacaine with midazolam as adjuvant in patient undergoing lower limb surgery. The purpose of the study is to compare the hemodynamic effects as well as onset of motor and sensory blockade. It also compares the duration of analgesia, duration of motor and sensory block intraoperatively and postoperatively |