| CTRI Number |
CTRI/2019/02/017400 [Registered on: 01/02/2019] Trial Registered Retrospectively |
| Last Modified On: |
14/01/2019 |
| 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 of two drugs (Dexmedetomidine and Fentanyl) which are used in epidural anaesthesia for lower limb surgery. |
|
Scientific Title of Study
|
Comparative study of Dexmedetomidine versus Fentanyl as an adjuvant to Ropivacaine (0.75%) in Epidural Anaesthesia in Lower Limb Orthopaedic Surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijayalaxmi Biradar |
| Designation |
Junior resident |
| Affiliation |
S.S.G. Hospital, Vadodara |
| Address |
Dept. of Anesthesiology,
Medical college & SSGHospital, Baroda
Department of Anaesthesiology,
S.S.G. Hospital, Jail road, Opposite to Bharat Petroleum, Vadodara 390001, Gujarat.
Vadodara
GUJARAT
Vadodara 390001
India |
| Phone |
9638716764 |
| Fax |
|
| Email |
biradarvijaya06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Patel |
| Designation |
Associate Professor |
| Affiliation |
S.S.G. Hospital, Vadodara |
| Address |
Dept. of Anesthesiology, Medical college & SSG Hospital, Baroda
S.S.G Hospital, Jail road, Opposite to Bharat petroleum, Vadodara 390001, Gujarat.
Vadodara
GUJARAT
VADODARA 390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijayalaxmi Biradar |
| Designation |
Junior resident |
| Affiliation |
SSG Hospital, Baroda |
| Address |
dept. of Anesthesiology, medical college and S.S.G. Hospital, Vadodara 390001
Department of Anaesthesia
S.S.G. Hospital, Jail road, Opposite to Bharat petoleum, Vadodara 390001, Gujarat
Vadodara
GUJARAT
Vadodara 390001
India |
| Phone |
9638716764 |
| Fax |
|
| Email |
biradarvijaya06@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE AND S.S.G. HOSPITAL, BARODA, 390001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia SSG Hospital Vadodara |
| Address |
S.S.G. Hospital, Jail road, Opposite to Bharat petrol pump, Vadodara 390001, Gujarat |
| Type of Sponsor |
Government 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 |
| Vijayalaxmi Biradar |
Medical college and SSG Hospital, Baroda |
Department of Anaesthesia,
medical College and S.S.G. Hospital, Jail road, Opposite to Bharat petrol pump, Vadodara-390001.
Vadodara
GUJARAT |
9638716764
biradarvijaya06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research (IECHR), Medical college and SSG hospital, Baroda. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
It is an alpha 2 adrenergic agonist. Its dose is 1 microgram/kg.50 microgram of dexmedetomidine is administered through epidural route, single bolus dose is administered. |
| Comparator Agent |
Fentanyl |
It is an opioid. Dose is 1microgram/kg. 50 microgram is administered by epidural route, along with Ropivavaine, single bolus dose is administered. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist (ASA) Grade I and II, Patients scheduled for elective lower limb orthopaedic surgery (Unilateral or bilateral tibia and fibula surgeries like internal fixation , external fixation and plating).
|
|
| ExclusionCriteria |
| Details |
1. Patients’ refusal/unable to give consent.
2. Patients with ASA status III and IV.
3. Patients with allergy to amide local anaesthetics .
4. Patients on α 2 antagonists, ACE inhibitors and
calcium channel blockers, B blockers.
5. Patients with ischemic heart disease, heart block, Dysrhythmias.
6. Pregnant patients and Morbid obesity (BMI>35 kg/square meter).
7. Patients with Coagulopathy, Renal and liver impairment.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to onset of anaesthesia at T 10 dermatomal level (min) |
7 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To document duration of effective analgesia, to find out Level of sedation,to find out adverse effects. |
1,5,10 upto 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2015 |
| Date of Study Completion (India) |
30/11/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Epidural block is becoming more useful and versatile procedure as it gives opportunity to anaesthesiologists for anaesthesia as well as perioperative analgesia in lower limb orthopaedic surgeries. However epidural anaesthesia is frequently associated with haemodynamic fluctuations due to use of large volumes of local anaesthetic drugs. Hence various adjuvants have been used to prolong duration of intraoperative and post operative analgesia and to minimise the adverse effects of high doses of local anaesthetics. Dexmedetomidine and fentanyl are very good hypnotic, sedative and analgesic drugs when used as an adjuvant in epidural anaesthesia, both of these drugs have been used safely and effectively without any side effects. So keeping in mind their similar pharmacologic interactions and properties we planned prospective, randomised, clinical study to compare analgesic and sedative effects of both of these drugs when used epidurally as an adjuvant to ropivacaine in epidural anaesthesia in patients undergoing lower limb orthopaedic surgeries. The aims of study are to evaluate characteristics of sensory blockade, motor blockade, vital parameters, to evaluate level of sedation, duration of effective analgesia, to find out any adverse effects. |