| CTRI Number |
CTRI/2021/01/030305 [Registered on: 07/01/2021] Trial Registered Prospectively |
| Last Modified On: |
06/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study for comparison of bupivacaine alone bupivacaine plus dexmedetomidine and bupivacaine plus magnesium sulfate for prevention of shivering after spinal anaesthesia in prostate surgery. |
|
Scientific Title of Study
|
A comparative study to assess the efficacy and safety of intrathecal bupivacaine alone, intrathecal bupivacaine plus dexmedetomidine and intra thecal bupivacaine plus magnesium sulfate for the prevention of post spinal anaesthesia shivering in transurethral resection of prostate(TURP) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Kumar Saharan |
| Designation |
PG Student |
| Affiliation |
Dr S.N. Medical Jodhpur |
| Address |
Department of anaesthesiology and critical care, MDM Hospital, Dr S. N. Medical college jodhpur
Shashtri Nagar Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9462322433 |
| Fax |
|
| Email |
sunilksaharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M L Tak |
| Designation |
Senior Professor |
| Affiliation |
Dr S.N. Medical Jodhpur |
| Address |
Department of anaesthesiology and critical care, MDM Hospital, Dr S. N. Medical college jodhpur
Shashtri Nagar Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9309087757 |
| Fax |
|
| Email |
takml88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Kumar Saharan |
| Designation |
PG Student |
| Affiliation |
Dr S.N. Medical Jodhpur |
| Address |
Department of anaesthesiology and critical care, MDM Hospital, Dr S. N. Medical college jodhpur
Shashtri Nagar Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9462322433 |
| Fax |
|
| Email |
sunilksaharan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN Medical college, Shashtri Nagar , Jodhpur
PIN- 342003 |
|
|
Primary Sponsor
|
| Name |
Dr SN Medical college and associated group of hospitals Jodhpur |
| Address |
Dr SN Medical college, Shashtri Nagar , Jodhpur PIN- 342003 |
| 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 Sunil Kumar Saharan |
Dr SN Medical college and associated group of hospitals Jodhpur |
Department of anaesthesiology and critical care, main surgical operation theatre No.5,First floor, MDM Hospital Jodhpur PIN-342003
Jodhpur
RAJASTHAN |
9462322433
sunilksaharan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Sampurnanand Medical College Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Central neuraxial block - spinal anaesthesia |
The comparative agents are given in the sub-arachnoid space via spinal needle using LOR technique to assess the efficacy and safety in preventing post spinal anaesthesia shivering. |
| Comparator Agent |
Group A - injection Bupivacaine
group B - injection bupivacaine with dexmedetomidine
group C - injection Bupivacaine with MgSo4 |
Group A - Injection bupivacaine 0.5% 12.5mg 2.5ml + 0.5ml of 0.9% NS.
Group B -Injection bupivacaine 0.5% 12.5mg 2.5ml + 0.5 ml of 5 mcg dexmedetomidine.
Group C - Injection bupivacaine 0.5% 12.5mg 2.5ml + 0.5 ml of 25 mg MgSo4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Male patients of ASA grade I and II of age 18-60 years posted for transurethral resection of prostate suitable for administration of regional anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients refusal, BMI>28.0, spinal abnormality, patients with CKD, any contraindication to spinal anaesthesia like sepsis, abnormal coagulation profile, emergency surgery, infection at site of injection, allergy to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of intrathecal bupivacaine alone, bupivacaine plus dexmedetomidine and bupivacaine plus magnesium sulfate group in terms of incidence and intensity of shivering |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety of intrathecal bupivacaine alone, bupivacaine plus dexmedetomidine and bupivacaine plus magnesium sulfate group in terms of hypothermia sedation score and complication including hypotension, bradycardia, nausea, vomiting and total dose of pethidine required to control shivering |
3 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
10/01/2021 |
| 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="0"
Months="3"
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
|
This study " A comparative study to assess the efficacy and safety of intrathecal bupivacaine alone, intrathecal bupivacaine plus dexmedetomidine and intrathecal bupivacaine plus magnesium sulfate for the prevention of post spinal anaesthesia shivering in transurethral resection of prostate (TURP)" will be done at Dr SN Medical college and associated group of hospitals Jodhpur (Rajasthan), after obtaining informed consent from the patients, under the guidance of my guide and the study is approved by institutional ethical committee -Dr Sampurnanand Medical College Jodhpur. There will be no financial burdon on the patients. |