CTRI Number |
CTRI/2023/11/060123 [Registered on: 22/11/2023] Trial Registered Prospectively |
Last Modified On: |
21/11/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
comparison of low dose clonidine and dexmedetomidine as a supportive agent
to levobupivacaine in spinal anaesthesia |
Scientific Title of Study
|
comparative evaluation of low dose intrathecal clonidine and dexmedetomidine as an adjuvant to levobupivacaine in subarachnoid block |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Kanishka Sharma |
Designation |
PG Resident |
Affiliation |
School of Medical Sciences and Research Sharda University Greater Noida |
Address |
Department of Anaesthesiology
School of Medical Sciences and
Research Sharda University Greater Noida Gautam Budh Nagar 201306 UP
Gautam Buddha Nagar UTTAR PRADESH 201306 India |
Phone |
9897794091 |
Fax |
|
Email |
2022008299.kanishka@pg.sharda.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manish Kumar Agarwal |
Designation |
Associate Proffessor |
Affiliation |
School of Medical Sciences and Research Sharda University Greater Noida |
Address |
Department of Anaesthesiology
School of Medical Sciences and Research Sharda University Gautam Budh Nagar 201306 UP
Gautam Buddha Nagar UTTAR PRADESH 201306 India |
Phone |
09838706199 |
Fax |
|
Email |
dr.manishagarwal09@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manish Kumar Agarwal |
Designation |
Associate Professor |
Affiliation |
School of Medical Sciences and Research Sharda University Greater Noida |
Address |
Department of Anaesthesiology
School of Medical Sciences and Research Sharda University Gautam Budh Nagar 201306 UP
Gautam Buddha Nagar UTTAR PRADESH 201306 India |
Phone |
09838706199 |
Fax |
|
Email |
dr.manishagarwal09@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology
School of Medical Sciences and Research, Sharda University. |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology School of Medical Sciences and Research Sharda University. |
Address |
plot no. 32,34 knowledge park 3, Greater Noida, Gautam Budh Nagar , Uttar Pradesh 201306 India |
Type of Sponsor |
Private 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 Manish Kumar Agarwal |
Sharda Hospital Sharda University |
Department of Anaesthesia 2nd Floor B Block SMS&R Greater Noida Gautam Buddha Nagar UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH |
9838706199
dr.manishagarwal09@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, School of Medical Sciences and Research, Sharda University |
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 |
Comparator Agent |
Clonidine and Dexmedetomidine |
comparative evaluation of low dose intrathecal clonidine 15 mcg and dexmedetomidine 10 mcg initially as an adjuvant to levobupivacaine in subarachnoid block in surgery lasting 2 hours |
Intervention |
levobupivacaine
clonidine and dexmedetomidine |
comparative evaluation of low dose intrathecal clonidine 15 mcg and dexmedetomidine 10 mcg initially as an adjuvant to levobupivacaine in subarachnoid block for sugery lasting 2 hours |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patient scheduled for surgery under subarachnoid block
2.Age 18-60 years
3.Both genders
4.ASA grade I and II
|
|
ExclusionCriteria |
Details |
1.Morbid obesity BMI>30kg permeter square
2.Patient with history of adverse response to study drugs
3.Patient with pre-existing neurological or spinal disease cardiovascular disease renal hepatic or any other systemic disease
4.Pregnant females
5.Coagulopathy or bleeding diathesis
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
To compare the effect of low dose intrathecal clonidine versus dexmedetomidine as anadjuvant to 0.5 percentage hyperbaric levobupivacaine in subarachnoid block in respect to
1.To compare the time of onset & duration of sensory blockade assessed by pinprick & Visual Analog Score VAS respectively.
2.To compare the time of onset & duration of motor blockade assessed by modified Bromage scale
|
Post operative period |
|
Secondary Outcome
|
Outcome |
TimePoints |
Changes in vitals parameters heart rate noninvasive blood pressure & oxygen saturation SPo2
2. Requirementoffirst analgesicrescueinpostoperativeperiodin thefirst 24hours.
|
Post operative perriod |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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 2/ Phase 3 |
Date of First Enrollment (India)
|
01/12/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
01/12/2023 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" 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
|
Central
neuraxial blockade is the most popular technique of anaesthesia for lower
limb surgeries. It is having several advantages like easy technique, economic
and provides good quality of anesthesia. It decreases blood loss, avoid risk of
intubation and aspiration, provides early ambulation Bupivacaine is
most commonly used local anaesthetic drug for spinal anaesthesia
but cardiotoxicity is the limiting factor. Levobupivacaine is having similar clinical profile with less cardio toxicity
than Bupivacaine is gaining popularity It has demonstrated less affinity and strength of inhibitory effect on
the inactivated state of cardiac sodium channels than the Bupivacaine and faster
protein binding rate. To
provide good quality of intra operative anesthesia with postoperative analgesia different additives like Opioids, Ketamine, Midazolam, Neostigmine andα2
adrenergic agonist are usedAlpha-2
adrenergic agonists have both analgesic and sedative properties when used as adjuvants to regional
anesthesia. By action at the α2-receptor in spinal and supraspinal sites, they potentiate
the effect of local anesthetics and allow a decrease in the required doses. These
salutary effects are achieved without causing respiratory depression or
excessive sedation. Clonidine is a
selective partial α-2 adrenergic agonist provides effective, prolonged and
dose dependent analgesia with a consequently decreased requirement of
supplemental analgesics. The α2 adrenergic agonist clonidine has a variety of different actions,
including the ability to potentiate the effects of local anesthetics. However, unlike
spinal opioids, clonidine does not produce pruritis or respiratory depression. Dexmedetomidine,
a highly selective α2 adrenergic agonist has emerged as a valuable adjunct to
regional anesthesia and analgesia. It has become of the frequently used drugs,
due to its hemodyanamic, sedative, anxiolytic, analgesic, neuroprotective and
anaesthetic sparingeffects. Extensive search
of literature reveals that though the studies have been conducted with
our additives with the drug bupivacaine, but a specific study comparing the
additive effect of both the drugs with the recently introduced drug
Levobupivacaine and a suitable dose required intrathecally has not done
extensively. Therefore, the present study is designed to compare the effect of
intrathecal clonidine and dexmedetomidine as an adjuvant to Levobupivacaine in
subarachnoid block. The specific
outcome measures to define the performance of our study will primarily
include comparing the effect of both the adjuvant drugs administered on the
duration of motor and sensory blockade. |