| CTRI Number |
CTRI/2021/05/033600 [Registered on: 13/05/2021] Trial Registered Prospectively |
| Last Modified On: |
10/05/2021 |
| 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
|
A STUDY TO COMPARE EFFECTS OF ADDITIVES IN SPINAL ANAESTHESIA IN LOWER LIMB ORTHOPAEDIC SURGERIES : BUPIVACAINE WITH DEXMEDITOMIDINE VS BUPIVACAINE WITH FENTANYL. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF EFFICACY OF INTRATHECAL 0.5% BUPIVACAINE WITH DEXMEDETOMIDINE VS 0.5% BUPIVACAINE WITH FENTANYL IN PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES : A RANDOMISED DOUBLE BLIND CONTROLLED TRIAL . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JIDNYASA MOON |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Institute Of Medical Science, Sevagram. |
| Address |
Department of Anaesthesiology,Mahatma Gandhi Institute Of Medical Science, Sevagram.
Wardha
MAHARASHTRA
442102
India |
| Phone |
9405903734 |
| Fax |
|
| Email |
jidnyasa09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucheta Tidke |
| Designation |
Head of The Department |
| Affiliation |
Mahatma Gandhi Institute Of Medical Science, Sevagram. |
| Address |
Department of Anaesthesiology,Mahatma Gandhi Institute Of Medical Science, Sevagram.
Wardha
MAHARASHTRA
442102
India |
| Phone |
9850510019 |
| Fax |
|
| Email |
suchetatidke@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
JIDNYASA MOON |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Institute Of Medical Science, Sevagram. |
| Address |
Department of Anaesthesiology,Mahatma Gandhi Institute Of Medical Science, Sevagram.
Wardha
MAHARASHTRA
442102
India |
| Phone |
9405903734 |
| Fax |
|
| Email |
jidnyasa09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute of Medical Science, Sevagram ,Wardha, Maharashtra. |
|
|
Primary Sponsor
|
| Name |
MGIMS Sevagram |
| Address |
Department of Anaesthesiology,Mahatma Gandhi Institute Of Medical Science, Sevagram , Wardha ,Maharashtra. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jidnyasa Moon |
MGIMS |
Department of Anaesthesia
Wardha
MAHARASHTRA |
9405903734
jidnyasa09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
0.5% BUPIVACAINE WITH DEXMEDETOMINE |
3ml of 0.5% hyperbaric Bupivacaine with 0.5ml of 5mcg Dexmedetomidine ,A total of 3.5ml |
| Comparator Agent |
0.5% BUPIVACAINE WITH FENTANYL |
3ml of 0.5% hyperbaric Bupivacaine with 0.5ml of 25mcg Fentanyl ,A total of 3.5ml |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists Grade I and II patients.
Age 20-60 years of either gender.
Patients undergoing lower limb Surgeries .
Patients free from cardiac and respiratory dysfunction.
Height is more than 4 feet. |
|
| ExclusionCriteria |
| Details |
American Society of Anesthesiologists Grade III and IV patients.
Patients with known contraindications for spinal anaesthesia: bleeding disorders, local infection.
Patients with haemodynamic instability.
Patients with comorbidities like Hypertension, Diabetes Mellitus, cardiac diseases,etc.
Patient with allergy to or history of hypersensitivity to local anaesthetics.
Emergency surgeries.
Patient with known allergy to opioids.
Patients with a history of severe PDPH or PONV after spinal anaesthesia.
Patient’s refusal.
Orthopaedic Surgeries requiring level of block above T8.
Lower limb orthopaedic surgeries around Hip joint.
Joint replacement surgeries.
Orthopaedic surgeries requiring prolonged duration of action that will
require supplementation with epidural catheterization or general anaesthesia.
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmeditomidine & 0.5% Bupivacaine with Fentanyl in terms of the duration of sensory and motor blockade.
|
Till 120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmedetomidine & 0.5% Bupivacaine with Fentanyl in terms of The onset of sensory and motor blocks achieved.
The level of blockade achieved .
The efficacy of postoperative analgesia .
Side effects like hemodynamic changes ( hypotension and bradycardia) ,sedation, pruritus, post-operative nausea and vomiting and respiratory depression.
|
till 120 minutes |
|
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Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/07/2021 |
| 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="3"
Months="0"
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)?
Response - NO
|
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Brief Summary
|
A Randomised Double Blind Controlled Trail to study the efficacy of intrathecal 0.5% Bupivacaine with Dexmedetomidine vs 0.5% Bupivacaine with Fentanyl in 104 patients of lower limb orthopaedic surgeries. The primary objective is to study the duration of anaesthesia. The secondary objectives are to compare onset of block, level of bock , side effects and postoperative analgesia . |