| CTRI Number |
CTRI/2023/06/054099 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
12/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study and compare the analgesic effect of Dexmedetomidine with Levobupivacaine, Ropivacaine and Bupivacaine under spinal anesthesia. |
|
Scientific Title of Study
|
To study the efficacy of Dexmedetomidine as an adjuvant to hyperbaric preparations of 0.5% Levobupivacaine, 0.75% Ropivacaine & 0.5% Bupivacaine in the patients undergoing surgeries under subarachnoid block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritika |
| Designation |
P G Student Ist Year |
| Affiliation |
N C Medical College and Hospital Israna Panipat |
| Address |
NC Medical College and Hospital
Israna Panipat
Panipat
HARYANA
132107
India |
| Phone |
7015316332 |
| Fax |
|
| Email |
abhireet12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mridul M Panditrao |
| Designation |
HOD |
| Affiliation |
N C Medical College and Hospital Israna Panipat |
| Address |
Department of Anesthesiology and Critical Care
NC Medical College and Hospital
Israna Panipat
Panipat
HARYANA
132107
India |
| Phone |
6280581885 |
| Fax |
|
| Email |
drmmprao1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika |
| Designation |
P G Student Ist Year |
| Affiliation |
N C Medical College and Hospital Israna Panipat |
| Address |
Department of Anesthesiology and Critical Care
NC Medical College and Hospital
Israna Panipat
Panipat
HARYANA
132107
India |
| Phone |
7015316332 |
| Fax |
|
| Email |
abhireet12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care
NC Medical College and Hospital Israna Panipat
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Critical Care |
| Address |
NC Medical College and Hospital
Israna Panipat |
| 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 Ritika |
NC Medical College Israna Panipat |
Department of Anesthesiology and Critical Care
NC Medical College and Hospital
Panipat
HARYANA |
7015316332
abhireet12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NC Medical College and Hospital |
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 |
subarachnoid block |
3.5 ml hyperbaric bupivacaine
3.5 ml hyperbaric levobupivacaine
3.5 ml hyperbaric ropivacaine
12.5mcg of dexmedetomidine in each group for duration approx 2 hrs surgergy |
| Comparator Agent |
Bupivacaine |
3.5 ml hyperbaric 0.5% bupivacaine |
| Comparator Agent |
Levobupivacaine |
3.5 ml hyperbaric levobupivacaine |
| Comparator Agent |
Ropivacaine |
3.5 ml hyperbaric ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Consent from patients and ASA grading I-II posted for lower abdominal and lower limb surgical procedures planned under subarachnoid block. |
|
| ExclusionCriteria |
| Details |
Non consenting as well pregnant patients, any spinal deformities, infection at the site,uncontrolled co-existing systemic and metabolic diseases, history of alcohol abuse, known sensivity to any LAAs and dexmedetomidine shall be excluded from the study , patients on beta blockers and sinus bradycardia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset, peak & level of Sensory block ( in seconds)
Onset, peak & level of Motor block ( in seconds)
Total duration of Analgesia (in minutes)
Time for rescue Analgesia (in minutes)
Total doses & amount (in mg ) of rescue analgesia
Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) |
Onset, peak & level of Sensory block ( in seconds)
Onset, peak & level of Motor block ( in seconds)
Total duration of Analgesia (in minutes)
Time for rescue Analgesia (in minutes)
Total doses & amount (in mg ) of rescue analgesia
Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out side effects & complications, if any. |
VAS monitoring continued every 6 hours for next 24 hours.
V0 :- VAS at the time of giving spinal (T0)
V1:- peak of sensory block (T3)
V2:- 2 segment regression (T5)
V3:- injection of rescue analgesia (T6)
V4:- at the time of shifting to the ward (T7)
V5,V6,V7 & V8 will be the measurement of VAS for next 24 hours.
After 24 hours, patient will be shifted to systemic analgesics & released from the study. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abhireet12@gmail.com].
- For how long will this data be available start date provided 10-11-2024 and end date provided 30-11-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To evaluate and compare the analgesic effect of addition of Dexmedetomidine as an adjuvant to hyperbaric preparations of 0.5% Levobupivacaine, 0.75% Ropivacaine and 0.5% Bupivacaine in the patients undergoing lower abdominal and lower limb surgeries under subarachnoid block and also to study the side effects and complications if any, intraoperatively as well as post operatively. |