| CTRI Number |
CTRI/2021/01/030445 [Registered on: 13/01/2021] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| 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 ISOBARIC ROPIVACAINE AND DEXMEDETOMIDINE IN SPINAL ANAESTHESIA |
|
Scientific Title of Study
|
The Effect of Adding Epinephrine To Combination of 0.75% Ropivacaine
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 ANAESTHESIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
TRAUMA CENTER
IMS, BHU
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shekhar Anand |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
TRAUMA CENTER
IMS, BHU
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAGYA SHUKLA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
Department of anaesthesiology
TRAUMA CENTER
IMS BHU
VARANASI
TRAUMA CENTER
IMS BHU
Varanasi
UTTAR PRADESH
221106
India |
| Phone |
09637233147 |
| Fax |
|
| Email |
shukla.pragya0509@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATIENTS AT TRAUMA CENTER IMS BHU |
|
|
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 SANDEEP LOHA |
TRAUMA CENTER INSTITUTE OF MEDICAL SCIENCES BHU |
DEPARTMENT OF ANAESTHESIOLOGY
1ST FLOOR TRAUMA CENTER
IMS, BHU
VARANASI
Varanasi
UTTAR PRADESH |
8660919866
drsandeepscb@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: V99||Unspecified transport accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A- Combination of ropivacaine 0.75% and Dexmedetomidine and Epinephrine 1:1000 |
Group A- Ropivacaine 0.75% 2.0 ml (150mg), Dexmedetomidine 0.5 ml (10 mcg) and Epinephrine 1:1000 0.5 ml (100mcg). Immediately after giving spinal anaesthesia the patient will be turned to supine position. 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. |
| Comparator Agent |
GROUP B- Combination of Ropivacaine 0.75% and Dexmedetomidine and normal saline. |
Group B- Ropivacaine 0.75% 2.0 ml (150 mg), Dexmedetomidine 0.5 ml (10 mcg) and normal saline 0.5 ml.
Immediately after giving spinal anaesthesia the patient will be turned to supine position. 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 given at the L3-4 level in sitting position. |
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 1 & 2
Lower limb surgery of probable duration of 2hrs.
|
|
| ExclusionCriteria |
| Details |
Patients refusal
Contradiction to regional anaesthesia
Coagulopathy
History of significant coexisting diseases like ischemic heart disease, hypertension, impaired renal functions, rheumatoid arthritis, and severe liver disease
Pregnant patients
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 |
After 2 hours every 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory block and motor block |
After 2 hours every 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/01/2021 |
| Date of Study Completion (India) |
13/07/2023 |
| 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
|
The study is designed to evaluate intrathecal anaesthesia and postoperative analgesia by adding epinephrine to combination of ropivacaine and dexmedetomidine.
In earlier studies dexmedetomidine with ropivacaine provids early sensory blockade, prolonged duration of sensory and motor blockade in patients undergoing intrathecal anesthesia for lower limb surgeries with no sedation. On the other hand epinephrine, a vasoconstrictor, reduces absorption of local anesthetics into the bloodstream when used as an adjuvant. Therefore, it reduces the systemic toxicity of local anesthetics and extends the duration of anesthesia.
We hypothesized that intrathecal isobaric 0.75% ropivacaine with dexmedetomidine and 1:1000 adrenaline would be comparable to isobaric 0.75% ropivacaine with dexmedetomidine and normal saline, for the efficacy of anesthesia and analgesia, and in addition would provide a better postoperative recovery profile and readiness for discharge. The purpose of the present study is to observe the effect of mentioned study drugs in intrathecal anaesthesia for duration of sensory and motor block with duration analgesia. |