| CTRI Number |
CTRI/2022/05/042465 [Registered on: 11/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of dexmedetomidine to ropivacaine heavy in spinal anaesthesia in lower limb surgeries. |
|
Scientific Title of Study
|
Comparison of dexmedetomidine as an adjuvant to ropivacaine heavy in spinal anaesthesia in lower limb surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drkiran yadav |
| Designation |
post graduate resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Anaesthesia,Mahatma Gandhi Medical College and Hospital, Sitapura,Jaipur, Rajasthan, India
2nd floor ,Department of Anaesthesia,main building,Mahatma Gandhi Medical College and hospital,Sitapura,Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7740920612 |
| Fax |
|
| Email |
dr.kiranyadav93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKalpana verma |
| Designation |
Associate Professor |
| Affiliation |
mahatma gandhi medical college and hospital |
| Address |
Department of anaesthesia, Mahatma Gandhi Medical College and Hospital ,Sitapura, Jaipur.
2nd floor,main hospital building ,,Mahatma Gandhi Medical College and Hospital,Sitapura,Jaipur.
Jaipur
RAJASTHAN
302022
India |
| Phone |
9588079916 |
| Fax |
|
| Email |
Kalpana2007.KV@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDurga Jethava |
| Designation |
Head of Department |
| Affiliation |
mahatma gandhi medical college and hospital |
| Address |
Department of anaesthesia,mahatma gandhi medical college and hospital,sitapura, jaipur
2nd floor,main hospital building ,mahatma gandhi medical college and hospital,sitapura, jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680064336 |
| Fax |
|
| Email |
djethava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Mahatma gandhi medical college & hospital sitapura jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College |
| Address |
Sitapura jaipur rajasthan india |
| 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 |
| Dr Kiran yadav |
Mahatma Gandhi medical college and hospital |
Operation theatre,department of anaesthesia
Jaipur
RAJASTHAN |
7740920612
dr.kiranyadav93@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 |
Ropivacaine 0.75% heavy |
Ropivacaine 0.75% heavy with 0.1ml saline will been given through spinal anaesthesia in lower limb surgeries. |
| Comparator Agent |
Ropivacaine 0.75% heavy with 10mcg(0.1ml) Dexmedetomidine. |
Ropivacaine 0.75% heavy with 10mcg(0.1ml) Dexmedetomidine in spinal anaesthesia in lower limb surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient posted for lower limb surgeries.
Patient posted for lower limb surgeries under spinal anaesthesia.
Patient with American Society Of Anaesthesiologists(ASA) class I and II. |
|
| ExclusionCriteria |
| Details |
Patient with ASA class III,IV,V.
Non-consenting patients.
Patient with pre-existing cardiac diseases
Severe renal or hepatic dysfunction.
Patient with known allergy to study drugs. |
|
|
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 |
| To study the time to two segment regression of block. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the time for need of resue postoperative analgesia in first 24 hours.
2)To compare hemodynamics of the patients. |
24 hours |
|
|
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)
|
15/05/2022 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
We compare effect of dexmedetomidine as an adjuvant to ropivacaine in spinal anaesthesia in lower limb surgeries, to study the time to two segment regression of block and to assess the time for need of rescue postoperative analgesia in first 24 hours and to compare the hemodynamics of the patients. To observe sensory onset (T10) mins, Motor onset (Modified bromage score 3) mins, Two segment regression of two sensory level(mins), Regression of Modified bromage score to 0 (mins), Time of first requirement of analgesia (hour).Intraoperative Adverse effects, Post-operative side effects over a period of 24 hours. |