| CTRI Number |
CTRI/2019/03/017895 [Registered on: 01/03/2019] Trial Registered Prospectively |
| Last Modified On: |
28/02/2019 |
| 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 between two doses of Dexmedetomidine through Epidural Infusion for Post-operative Pain Relief |
|
Scientific Title of Study
|
Comparison Between Two Different Doses of Dexmedetomidine through Continuous Epidural Infusion For Postoperative Analgesic Efficacy And Safety in Lower Limb Surgeries – Prospective Randomized Double-Blind Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sam Blessy Sheba |
| Designation |
PG Resident |
| Affiliation |
Sri Balaji Vidyapeeth |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Tiruporur-Guduvancherry Main Road, Chengalpet, Kancheepuram, Nellikuppam, Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8870065709 |
| Fax |
|
| Email |
bless_1203@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjali Kurherkar |
| Designation |
Professor |
| Affiliation |
Sri Balaji Vidyapeeth |
| Address |
Department of Anaesthesiology(2nd Floor)
Shri Sathya Sai Medical College and Research Institute
Tiruporur-Guduvancherry Main Road, Chengalpet, Kancheepuram, Nellikuppam, Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9486414942 |
| Fax |
|
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sam Blessy Sheba |
| Designation |
PG Resident |
| Affiliation |
Sri Balaji Vidyapeeth |
| Address |
Department of Anaesthesiology(2nd Floor)
Shri Sathya Sai Medical College and Research Institute
Tiruporur-Guduvancherry Main Road, Chengalpet, Kancheepuram, Nellikuppam, Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8870065709 |
| Fax |
|
| Email |
bless_1203@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Sam Blessy Sheba |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Tiruporur-Guduvancherry Main Road, Chengalpet, Kancheepuram, Nellikuppam, Ammapettai, Tamil Nadu 603108 |
| 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 |
| Sam Blessy Sheba |
Shri Sathya Sai Medical College and Research Institute |
Department of Anaesthesiology 2nd Floor
OT complex
Tiruporur-Guduvancherry Main Road, Chengalpet, Kancheepuram, Nellikuppam, Ammapettai, Tamil Nadu 603108
Kancheepuram
TAMIL NADU |
08870065709
bless_1203@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M96-M96||Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Postoperative Continuous Epidural Infusion for analgesia
Divided into two groups:
•Group 1 will receive Epidural Infusion 0.1% Ropivacaine + 0.5µg/kg/24hours of Dexmedetomidine, total dose of 5ml/hr over period of 48 hours
•Group 2 will receive Epidural Infusion 0.1% Ropivacaine + 1µg/kg/24hours of Dexmedetomidine, total dose of 5ml/hour over a period of 48 hours
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sex undergoing lower limb surgeries under Combined Spinal and Epidural Anaesthesia (CSEA) willing to be included in the study
|
|
| ExclusionCriteria |
| Details |
1.Patients with Cardiac pathology
2.Hypertension
3.BMI <18 or >30 kg/m2
4.Known allergy to local anaesthetic infiltration
5.Chronic use of any other analgesics
6.American Society of Anaesthesiologists (ASA) III and above
7.Pregnant patients
8.Refusal for consent
|
|
|
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 analgesic efficacy in terms of Pain Scores in the first 24 hours postoperatively.
|
To compare analgesic efficacy in terms of Pain Scores in the first 24 hours postoperatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To compare safety profile measured by sedation score and hemodynamic parameters up to 48 hours post operatively
•To compare pain scores in the next 24 hours, up to 48 hours postoperatively
|
Postoperatively
Postoperatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Randomized Double blind-study to compare analgesic efficacy and safety of two different doses of Dexmedetomidine for continuous Epidural post-operative analgesia in lower limb surgeries. Primary outcome is to compare analgesic efficacy in terms of Pain Scores in the first 24 hours postoperatively. The secondary outcome is to compare the safety profile measured by sedation score and hemodynamic parameters up to 48 hours postoperatively and to compare pain scores in the next 24 hours, up to 48 hours postoperatively |