| CTRI Number |
CTRI/2021/01/030357 [Registered on: 11/01/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFECT OF ADDING EPINEPHRINE TO COMBINATION OF BUPIVACAINE AND DEXMEDETOMIDINE IN SPINAL ANAESTHESIA FOR LOWER LIMB SURGERIES |
|
Scientific Title of Study
|
The Effect of Adding Epinephrine To Combination of 0.5% Hyperbaric Bupivacaine and Dexmedetomidine in Intrathecal Anaesthesia- A
Prospective, Double Blinded Randomized Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shekhar Anand |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
Department of anaesthesia 1st floor
TRAUMA CENTER
IMS BHU
TRAUMA CENTER IMS BHU VARANSI 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shekhar Anand |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
ROOM NO 05 SUSHRUT MEDICAL HOSTEL TRAUMA CENTER BHU
TRAUMA CENTER IMS BHU VARANSI 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shekhar Anand |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
Department of anesthesiology
1st floor
TRAUMA CENTER BHU
Varanasi
TRAUMA CENTER IMS BHU VARANSI 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
|
Source of Monetary or Material Support
|
| TRAUMA CENTER
IMS BHU VARANASI |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE ] |
|
|
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 GHANSHYAM YADAV |
TRAUMA CENTER IMS BHU |
Department of anaesthesiology 1st floor
TRAUMA CENTER LANKA BHU
VARANASI
Varanasi
UTTAR PRADESH |
9838894169
ghanshyambhu1976@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BANARAS HINDU UNIVERSITY |
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: S70-S79||Injuries to the hip and thigh, (3) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (4) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMBINATIONOF 0.5% HYPERBARIC BUPIVACAINE AND DEXMEDETOMIDINE |
Onset of sensory block to level T10, maximum height of dermatome achieved, onset of motor blockade to Bromage scale 3, regression of sensory level to dermatome S1 and return of motor activity Bromage 0 levels, total duration of analgesia will be recorded. Sedation score will also be recorded every 10-min interval for the first 30 min and then every 15-min interval till the completion of surgery.
|
| Comparator Agent |
EPINEPHRINE TO COMBINATION OF 0.5% HYPERBARIC BUPIVACAINE AND DEXMEDETOMIDINE |
Onset of sensory block to level T10, maximum height of dermatome achieved, onset of motor blockade to Bromage scale 3, regression of sensory level to dermatome S1 and return of motor activity to Bromage 0 level, total duration of analgesia will be recorded.Sedation score will also be recorded every 10-min interval for the first 30 min and then every 15-min interval till the completion of surgery.
|
| Intervention |
INTRATHECAL ANAESTHESIA FOR LOWER LIMB SURGERIES |
The drug solutions will be prepared and administered by an independent Anesthesiologist not involved in the study. Outcome parameters shall be recorded by the investigators. Intrathecal anaesthesia will be given by 25 G quincke needle at the L3-4 level in sitting position. Immediately after giving spinal anaesthesia the patient will be turned to supine position |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1 AND 2
LOWER LIMB SURGERIES WITH PROBABLE DURATION OF 2 HOURS |
|
| ExclusionCriteria |
| Details |
Patients refusal
Contraindication to regional anesthesia
Coagulopathy
History of significant coexisting diseases (IHD, impaired renal functions, and severe liver disease)
Chronic alcoholics and malnourished patients
Atrioventricular block, incomplete or partial heart blocks, or intake of beta blockers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
EVERY 15 MINUTES POST OPERATIVELY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory block & motor block |
EVERY 15 MINUTES POST OPERATIVELY |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2021 |
| Date of Study Completion (India) |
23/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is designed to evaluate intrathecal anesthesia and postoperative analgesia of adding epinephrine to a combination of 0.5% hyperbaric bupivacaine and dexmedetomidine. Dexmedetomidine, a highly selective α2 adrenergic agonist increases the duration of anesthesia & analgesia whereas Epinephrine, a vasoconstrictor, reduces the systemic toxicity by decreased absorption of local anesthetics into the bloodstream and extends the duration of anesthesia.
We are expecting that the decrease in heart rate and blood pressure with a combination of bupivacaine and dexmedetomidine is balanced by adrenaline as it increases the same resulting in prolonged anesthesia with better hemodynamic status. |