| CTRI Number |
CTRI/2023/03/050845 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
18/03/2023 |
| 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 analgesic effect of ropivacaine with dexmedetomidine and ropivacaine with clonidine in lower limb orthopaedic surgeries |
|
Scientific Title of Study
|
Efficacy of analgesic effect of dexmedetomidine versus clonidine added to intrathecal hyperbaric ropivacaine in lower limb orthopedic surgeries- a randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darpally Priyanka |
| Designation |
1st year Post graduate |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
A block, first floor, Department of Anaesthesiology Aarupadai veedu medical college and hospital
kirumampakkam puducherry
pondicherry
A block, first floor, Department of Anaesthesiology Aarupadai veedu medical college and hospital
kirumampakkam puducherry
pondicherry
Pondicherry
PONDICHERRY
603407
India |
| Phone |
8008109933 |
| Fax |
|
| Email |
priyankadaripally@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D Shanmugavalli |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of Anaesthesiology Aarupadai veedu medical college and hospital
kirumampakkam puducherry
pondicherry
Department of Anaesthesiology Aarupadai veedu medical college and hospital
kirumampakkam puducherry
pondicherry
Pondicherry
PONDICHERRY
603407
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
vallijegan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
E Shanmugavalli |
| Designation |
Associate professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of Anaesthesiology Aarupadai veedu medical college and hospital
kirumampakkam puducherry
pondicherry
Department of Anaesthesiology Aarupadai veedu medical college and hospital
kirumampakkam puducherry
pondicherry
Pondicherry
PONDICHERRY
603407
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
vallijegan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College & Hospital |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college and hospital |
| Address |
Department of Anaesthesiology Aarupadai veedu medical college and hospital
kirumampakkam puducherry
pondicherry |
| 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 |
| Darpally Priyanka |
Aarupadai veedu medical college and hospital |
Department of anaesthesiology
Aarupadai veedu medical college and hospital
Kirumampakkam Puducherry
Pondicherry
PONDICHERRY |
8008109933
priyankadaripally@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adjuvant : Dexmedetomidine and clonidine |
Dexmedetomidine 10mcg added to 0.75% ropivacaine and clonidine 30mcg added to 0.75% ropivacaine |
| Intervention |
Spinal Anaesthesia with 0.75% Ropivacaine |
Spinal Anaesthesia is the choice for lower limb Orthopaedic surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with 18-60 years
ASA I and ASA II
Weight - 50-80 kgs
Orthopaedic lower limb cases |
|
| ExclusionCriteria |
| Details |
ASA III and more
Hypersensitivity to any drugs used in study
Uncontrolled diabetic mellitus and hypertension
Cardiac dysrhythmias
Coagulopathies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post-operative analgesia of dexmedetomidine versus clonidine as adjuvant added to hyperbaric ropivacaine |
To compare post-operative dexmedetomidine versus Clonidine as adjuvant added to hyperbaric ropivacaine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Motor blockade
Sensory blockade |
Motor 7 hrs
Sensory 7hrs |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
28/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/03/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="28" |
|
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
|
Aim of my study is to assess and evaluate the analgesic effect of dexmedetomidine and clonidine added to 0.75% hyperbaric ropivacaine in spinal anesthesia in lower limb orthopedic surgeries with onset of anesthesia, duration of analgesia and hemodynamic changes Primary objective :- to compare the duration of post-operative analgesia by intrathecal administration of 0.75% hyperbaric ropivacaine with dexmedetomidine versus clonidine. |