| CTRI Number |
CTRI/2024/12/077606 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare Ropivacaine and Ropivacaine plus Dexmedetomidine in spinal anesthesia. |
|
Scientific Title of Study
|
A clinical prospective double blinded randomized controlled study to compare the intrathecal ropivacaine and dexmedetomidine with intrathecal ropivacaine in infraumblical surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Robin Arora |
| Designation |
PG Resident Anesthesia Second year |
| Affiliation |
Pacific Medical College and Hospital Udaipur |
| Address |
Pacific Medical College and Hospital
Bhilon Ka Bedla
Udaipur
RAJASTHAN
313001
India |
| Phone |
9634045505 |
| Fax |
|
| Email |
robinar1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Chandra Audichya |
| Designation |
Professor and Head of Department Anesthesia |
| Affiliation |
Pacific Medical College and Hospital Udaipur |
| Address |
Pacific Medical College and Hospital
Third Floor Anesthesia department
Bhilon Ka Bedla
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929721889 |
| Fax |
|
| Email |
Prakash.audichya10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Robin Arora |
| Designation |
PG Resident Anesthesia Second year |
| Affiliation |
Pacific Medical College and Hospital Udaipur |
| Address |
Pacific Medical College and Hospital
Department of Anesthesia
Bhilon Ka Bedla
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9634045505 |
| Fax |
|
| Email |
robinar1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Medica College and Hospital
Third Floor Department of Anesthesia
Bhilon a Bedla
Udaipur 313001
Rajasthan
India |
|
|
Primary Sponsor
|
| Name |
pacific medical college and hospital |
| Address |
Pacific Medical College and Hospital
Third Floor Anesthesia department
Bhilon Ka Bedla
Udaipur
313001
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 Prakash Chandra Audichya |
Pacific Medical College and Hospital,Udaipur |
Third Floor Anesthesia Department
Bhilon Ka Bedala
Udaipur 313001
Rajasthan
Inda
Udaipur
RAJASTHAN |
9929721889
Prakash.audichya10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N211||Calculus in urethra, (3) ICD-10 Condition: N210||Calculus in bladder, (4) ICD-10 Condition: S720||Fracture of head and neck of femur, (5) ICD-10 Condition: S822||Fracture of shaft of tibia, (6) ICD-10 Condition: S929||Unspecified fracture of foot and toe, (7) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Ropivacaine |
3 ml of intrathecal 0.75% injection hyperbaric ropivacaine with 0.5 ml of
normal saline.24 months |
| Comparator Agent |
Injection Ropivacaine plus Injection Dexmedetomidine |
3 ml of intrathecal 0.75% injection hyperbaric ropivacaine with 7 mcg preservative free 0.5 ml injection dexmedetomidine.24 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Age group 18–60 years of either sex.
-ASA physical status 1 and 2.
-Patients posted for Infraumbilical surgeries. |
|
| ExclusionCriteria |
| Details |
The following criteria were excluded from the study:
1. Patient refusal.
2. Patients with contraindication to spinal anaesthesia.
3. Patients with any systemic disease.
4. Allergy to either drug used in the study.
5. History of substance abuse. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Duration of analgesia
-Post operative analgesic requirement
-Side effects if any
-VAS score |
24 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia
Side effects if any |
24 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/12/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To assess safety and efficacy of intrathecal Heavy inj.Ropivacaine (3ml) plus Dexmedetomidine (7mcg) versus a combination of intrathecal Heavy inj.Ropivacaine (3ml) and normal saline |