| CTRI Number |
CTRI/2021/08/035513 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
04/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of two drugs,chloroprocaine and ropivacaine with adjuvant fentanyl in spinal anaesthesia for short surgeries |
|
Scientific Title of Study
|
RANDOMIZED DOUBLE-BLIND STUDY TO COMPARE INTRATHECAL 1% 2-CHLOROPROCAINE WITH FENTANYL AND 0.5% ROPIVACAINE WITH FENTANYL FOR SHORT SURGERIES UNDER SPINAL ANAESTHESIA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DESHMUKH AISHWARYA SHRINIVAS |
| Designation |
Junior resident academic |
| Affiliation |
Bharati Vidyapeeth ( Deemed to be university) medical college and research center,Dhankawadi ,pune |
| Address |
Bharati Vidyapeeth ( Deemed to be university) medical college and research center,Dhankawadi ,pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8217474217 |
| Fax |
|
| Email |
Aishudeshmukh222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR POOJA NARAYAN BHOSLE |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth ( Deemed to be university) medical college and research center,Dhankawadi ,pune |
| Address |
Bharati Vidyapeeth ( Deemed to be university) medical college and research center,Dhankawadi ,pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8128658765 |
| Fax |
|
| Email |
bhosle_pooja@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR POOJA NARAYAN BHOSLE |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth ( Deemed to be university) medical college and research center,Dhankawadi ,pune |
| Address |
Bharati Vidyapeeth ( Deemed to be university) medical college and research center,Dhankawadi ,pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8128658765 |
| Fax |
|
| Email |
bhosle_pooja@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Bhartiya Vidyapeeth (Deemed to be university) Medical college
and research center,Pune Maharashtra |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed To Be University Medical College and Research Centre Pune |
| Address |
Bharati Vidyapeeth Deemed To Be University
Medical College and Research Centre, Pune.
|
| 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 Deshmukh Aishwarya Shrinivas |
Bharati Vidyapeeth (Deemed To Be ) Medical College and Research Centre, Pune. |
Department of Anaesthesia ,Bharati Vidyapeeth
Medical College and Research Centre, Pune.
Pune
MAHARASHTRA |
08217474217
Aishudeshmukh222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhartia Vidyapeeth ( Deemed to be University) Medical college Pune, lnstitutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers of both the sex with age group of( 18 to 65yrs) for short surgeries under spinal anaesthesia |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intrathecal inj 0.5% ropicacaine. |
0.5% ropivacaine (3cc) with adjuvant inj fentanyl 12.5 mcg |
| Comparator Agent |
intrathecal inj 1% 2-chloroprocaine |
1% 2-chloroprocaine with adjuvant inj fentanyl 12.5mcg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA I/II for selection of patient.
2)duration of surgery less than 2 hrs. |
|
| ExclusionCriteria |
| Details |
1)Patients Refusal
2)infection on spinal region.
3)Patients with a history of severe cardiovascular disease, steroid use, renal or hepatic dysfunction and mental retardation
4)Known sensitivity to the drug to be used
5)Patients on anticoagulant therapy, coagulation disorder
6)Intolerance to Atypical plasma cholinesterase
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
. Post operative early regain of sensory block and motor block.
Haemodynamic stability after giving spinal anaesthesia in short surgeries.
. Duration of surgery
|
observation of motor and sensory block after spinal anaesthesia in short surgeries every 5 mins for 20 mins then every 10 mins upto end of surgery
2.Heart rate ,systolic blood pressure, diastolic blood pressure ,respiratory rate , oxygen saturation for every 5 mins for 10 minutes then every 10 minutes upto end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Early ambulation after surgery
.Early discharge of patient. |
.NIBP, heart rate, and SpO2 will be recorded. Sensory and motor block will be assessed every 15 minutes for 60 min and then every 30 minutes until complete regression
.Patient will be shifted to, ward from PACU when modified Aldert score would be ≥ 9. In the ward time of ambulation that is stand without support and walk and time of voiding of urine will be noted |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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 3 |
|
Date of First Enrollment (India)
|
15/08/2021 |
| 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="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
|
The study is randomized ,double blind, trial comparing the efficacy between the two drugs intrathecal 1% 2- chloroprocaine and 0.5% ropivacaine with adjuvant fentany (12.5 mcg)l in spinal anaesthesia for short surgeries . primary outcome will be duration of anaesthesia and haemodynamic stability, secondary outcome will be early ambulation and early discharge. |