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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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