| CTRI Number |
CTRI/2024/11/076796 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| 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
|
Dexmedetomidine as adjuvant with levobupivacaine for spinal anaesthesia in lower limb surgeries - A study of it Effects when given mixed or one after another |
|
Scientific Title of Study
|
Comparison of Subarachnoid Block in Mixed Versus Sequential Administration of Levobupivacaine and Dexmedetomidine in Lower Limb Surgeries: A Randomized Clinical Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Parma |
| Designation |
Resident doctor in Department of Anaesthesia |
| Affiliation |
Goverment Medical college Baroda |
| Address |
Anaesthesia Dept, 2nd floor new surgical building, Government Medical College , Baroda
Anaesthesia Dept, 2nd floor new surgical building, Government Medical College , Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9586869933 |
| Fax |
|
| Email |
poojaparmar1112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashmira Pander |
| Designation |
Assistant Professor |
| Affiliation |
Goverment Medical college Baroda |
| Address |
Anaesthesia Dept, 2nd floor new surgical building, Government Medical College , Baroda
Anaesthesia Dept, 2nd floor new surgical building, Government Medical College , Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9099045151 |
| Fax |
|
| Email |
dr.kashmira13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashmira Pander |
| Designation |
Assistant Professor |
| Affiliation |
Goverment Medical college Baroda |
| Address |
Anaesthesia Dept, 2nd floor new surgical building, Government Medical College , Baroda
Anaesthesia Dept, 2nd floor new surgical building, Government Medical College , Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9099045151 |
| Fax |
|
| Email |
dr.kashmira13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology SSG Hospital Vadodara 390001, Gujrat |
|
|
Primary Sponsor
|
| Name |
Goverment Medical college Baroda |
| Address |
Department of Anaesthesiology New surgical block SSG Hospital
Vadodara 390001 , Gujrat , India |
| 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 |
| Dr Pooja Parmar |
SSG Hospital Vadodara |
orthpeadic and surgery OT SSG Hospital vadodara
Vadodara
GUJARAT |
9586869933
poojaparmar1112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and health research government medical college baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M808||Other osteoporosis with current pathological fracture, (2) ICD-10 Condition: M229||Unspecified disorder of patella, (3) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine and Hyperbaric Levobupivacaine (sequentially) |
After preanesthetic evaluation
patients meeting inclusion
criteria will be selected .
operation theatre with all
necessary equipments and
drugs to be kept ready spinal
anaesthesia will be given in l3-
L4 intervertebral space. patients
will be randomly devided into
two groups . In this group Group
S - Inj Levobupivacaine 0.5% (12.5mg) 2.5 ml (in 5cc syringe) followed by Inj Dexmedetomidine (10mcg) 0.5ml (Diluted in Normal saline in 2cc syringe). (Two syringe technique – drugs will be loaded in two separate syringes) given in spinal anaesthesia . patient
will be turned supine and
then intraioperative vital
monitoring , spinal and motor
blockade , duration analgesia
,requirement of rescue
analgesia will be assessed for
24 hours |
| Intervention |
Dexmedetomidine with hyperbaric Levobupivacaine (Premixed) |
After preanesthetic evaluation
patients meeting inclusion
criteria will be selected .
operation theatre with all
necessary equipments and
drugs to be kept ready spinal
anaesthesia will be given in l3-
L4 intervertebral space. patients
will be randomly divided into
two groups . In this group Group M - Inj Levobupivacaine 0.5% (12.5mg) 2.5ml + Inj Dexmedetomidine (10mcg) 0.5 ml (Diluted in Normal saline).
(premix). Total drug prepared will be 3ml in a single 5cc syringe, given in spinal anaesthesia .
patient will be turned supine and then intraioperative vital
monitoring , spinal and motor
blockade , duration analgesia
,requirement of rescue
analgesia will be assessed for
24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA – I/II/III
Lower limb surgeries
Duration of surgery: 2 to 2.5 hrs
|
|
| ExclusionCriteria |
| Details |
Patients refusal.
Patients with absolute and relative contraindications to spinal anaesthesia Local skin infection, Vertebral column abnormalities, bleeding disorders, cardiopulmonary disease, neuropathies
Patients with allergy to study drugs.
Pregnant and lactating females.
BMI more than 30kg/ m2.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensory and Motor blockade characteristics
Onset of sensory block at L1 dermatomal level
Time to achieve maximum sensory level
Time for two segment regression
Total duration of sensory block
Onset of motor blockade
Time to achieve maximum motor blockade
Duration of motor blockade
|
Till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe any changes in hemodynamic parameters like pulse rate, systolic blood pressure, diastolic blood pressure, mean areterial pressure, SpO2 perioperatively.
Duration of effective analgesia - time from administration of drug intrathecally to pain score VAS ≥ 4 postoperatively.
Requirement of rescue analgesia in 24 hours.
To observe any complications like Bradycardia, Hypotension, Respiratory depression, urinary retention, Shivering.
|
till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim behind
performing this study is to see differences in sensory and motor block
characteristics along with determining
effects on haemodynamics while
intrathecal administration of premix hyperbaric Levobupivacaine and
Dexmedetomidine in single syringe or in two separate syringes.
58 patients for lower limb surgeries will be randomly
decided into two groups , In each group there will be 29 patients who are
posted for elective lower limb surgeries.
In one group Group M - - Inj Levobupivacaine
0.5% (12.5mg) 2.5ml + Inj Dexmedetomidine (10mcg) 0.5 ml (Diluted in Normal
saline). (premix). Total drug prepared will be 3ml in a single 5cc
syringe. In second group Group S - Inj Levobupivacaine 0.5% (12.5mg) 2.5
ml (in 5cc syringe) followed by Inj Dexmedetomidine (10mcg) 0.5ml (Diluted in
Normal saline in 2cc syringe). (Two syringe technique – drugs will be loaded in
two separate syringes).
Comparing Sensory and Motor block characteristics as
primary outcome
As a secondary outcome ,
hemodynamic parameters ,duration of effective analgesia , requirement of
rescue analgesia in 24 hours ,any complications will be assessed .
The proposed advantage of the study will be that
Dexmedetomidine and Levobupivacaine given sequentially results in faster onset
of sensory and motor block, prolongs the duration and reduces the postoperative
analgesic requirement as compared to premixed drugs .
|