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CTRI Number  CTRI/2023/05/052215 [Registered on: 02/05/2023] Trial Registered Prospectively
Last Modified On: 01/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparative study of Hyperbaric Levobupivacaine (0.5%) with Dexmedetomidine given intrathecally versus Hyperbaric Levobupivacaine (0.5%) with Dexmedetomidine given intravenously in patients undergoing lower abdominal and lower limb surgeries under spinal anesthesia 
Scientific Title of Study   Comparative study of Hyperbaric Levobupivacaine (0.5%) with Intrathecal Dexmedetomidine and Hyperbaric Levobupivacaine (0.5%) with Intravenous Dexmedetomidine in patients undergoing lower abdominal and lower limb surgeries under spinal anesthesia- A PROSPECTIVE RANDOMIZED DOUBLE-BLIND STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhishwar R 
Designation  PG Resident 
Affiliation  Chettinad Academy of Research and Education 
Address  Department of Anaesthesiology Chettinad Academy of Research and Education Chettinad health city RajivGandhi salai Kelambakkam Kancheepuram District

Kancheepuram
TAMIL NADU
603103
India 
Phone  9566338811  
Fax    
Email  bhishu2509@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anand S 
Designation  Professor  
Affiliation  Chettinad Academy of Research and Education 
Address  Department of Anaesthesiology Chettinad Academy of Research and Education Chettinad health city RajivGandhi salai Kelambakkam Kancheepuram District

Kancheepuram
TAMIL NADU
603103
India 
Phone  9444486183  
Fax    
Email  dranandmurugan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anand S 
Designation  Professor  
Affiliation  Chettinad Academy of Research and Education 
Address  Department of Anaesthesiology Chettinad Academy of Research and Education Chettinad health city RajivGandhi salai Kelambakkam Kancheepuram District

Kancheepuram
TAMIL NADU
603103
India 
Phone  9444486183  
Fax    
Email  dranandmurugan@gmail.com  
 
Source of Monetary or Material Support  
CHETTINAD ACADEMY OFF RESEARCH AND EDUCATION 
 
Primary Sponsor  
Name  ANAND S 
Address  Dr Anand S Professor of Department of Anaesthesiology Chettinad Academy of Research and Education Chettinad health city RajivGandhi salai Kelambakkam Kancheepuram district  
Type of Sponsor  Other [Self] 
 
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 
Bhishwar R  Chettinad Academy of Research and Education  Department of Anaesthesiology D block 1st floor Chettinad Academy of Research and Education Chettinad health city RajivGandhi salai Kelambakkam Kancheepuram district
Kancheepuram
TAMIL NADU 
9566338811

bhishu2509@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CARE IHEC-I  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  INTRATHECAL HYPERBARIC LEVOBUPIVACIANE (0.5%) WITH DEXMEDETOMIDINE 0.1ml (5 μg)   Patients will receive 100ml NS IV over 10 mins + 3 ml of Hyperbaric Levobupivacaine 0.5% and (0.1ml) Dexmedetomidine 5 μg Intrathecally. For Total duration of 120 minutes  
Intervention  INTRATHECAL HYPERBARIC LEVOBUPIVACIANE (0.5%) WITH INTRAVENOUS DEXMEDETOMIDINE (0.5ug/kg)  Patients will receive Intravenous Dexmedetomidine (0.5ug/kg) in 100 ml NS over 10 mins + 3 ml of Hyperbaric Levobupivacaine 0.5% and 0.1 ml of sterile water Intrathecaly For total duration of 120 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  -American Society of Anesthesiologists (ASA) grade I-II.
-Age group between 18-65 years.
-Scheduled for Lower abdominal surgeries.
-Both Elective and Emergency procedures.
 
 
ExclusionCriteria 
Details  -Patient refusal
-Patients using alpha 2‑adrenergic receptors antagonists, calcium channel blockers, angiotensin – converting enzyme inhibitors
-History of allergy to study drugs
-Post spinal surgeries, Spinal Deformities
-Pregnancy
-Coagulopathy
-Dysrhythmia
-Major Hepatic, Renal and Cardiovascular Dysfunction
-BMI >35
-Height <140cm
-Heart Rate <60/min
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
-To compare onset and duration of sensory blockade.
-To compare onset and duration of motor blockade.
 
Patient will be put in supine position soon after Sub arachnoid block motor and sensory blockade will assessed as baseline from the time of administration of test drug and each minute upto 15 minutes followed by every 15 minutes once upto 120 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To assess Hemodynamic changes and side effects if any  Patient’s HR, NIBP, SPO2 will be monitored at 3 min interval up to 15 minutes after that every 5 mins up to 60 mins after that every 10 mins until end of the procedure.  
To assess duration of analgesia.  Duraion of analgesia will be noted (onset of sensory block to onset of pain postoperatively- VAS more than 3
 
To assess sedation score  Ramsay Sedation score is monitored every 15 mins from the time of IV infusion for 2hrs intraoperatively and immediately at postoperative.
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   01/06/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Spinal anaesthesia is popular and commonly used worldwide. The advantage of an awake patient, minimal drug cost, excellent intraoperative anaesthesia, prolonged and satisfactory postoperative analgesia, rapid patient turnover has made this method of choice for many surgical procedures.

 The increase in day care surgery has generated a need for a local anaesthetic with a quick onset and shorter duration of action allowing early ambulation. Bupivacaine is the first long acting amide linked local anaesthetic with advantage over lignocaine in its longer duration of action. In the last few years, it’s pure enantiomers such as ropivacaine [amides] and levobupivacaine [amides], have been introduced in clinical practice because of lower toxic effects for cardiovascular and central nervous system.  

Levobupivacaine is a pure S(-) enantiomers of racemic bupivacaine, it is a long acting local anaesthetic with a relatively slow onset of action. It has a high potency. Levobupivacaine is equally lipophilic to bupivacaine but more than ropivacaine as ropivacaine has 3C side chain instead of 4C side chain as substitution of pipecoloxylidide.

 Dexmedetomidine is a highly lipophilic drug that gets rapidly absorbed into the cerebrospinal fluid and bind to alpha‐2‐adrenergic receptor of spinal cord to produce analgesia. It prolongs the duration of both sensory and motor blockade induced by local anesthetics irrespective of the route of administration whether epidural, caudal, or spinal. Intravenous dexmedetomidine is also known to prolong the duration of sensory block of local anesthetics during spinal anesthesia and peripheral nerve block but the underlying mechanism of this effect is unclear.There are very few evidences regarding efficacy of dexmedetomidine as neuraxial adjuvant.Dexmedetomidine is an alpha-2 adrenoreceptor agonist that is approved as an intravenous sedative and co-analgesic drug. It has an alpha2/alpha1 selectivity ratio which is eight times higher than that of clonidine. In previous clinical studies, intravenous dexmedetomidine resulted in a significant opioid sparing effect and decrease in inhalational anaesthetic requirements.  To improve the block characteristics of intrathecally administered low dose local anaesthetics, addition of adjuvant is must.  

Little information is available in the literature regarding the use of hyperbaric levobupivacaine along with dexmedetomidine as adjuvant to produce spinal block for ambulatory surgeries.


            The aim of this study is to compare the onset, duration of sensory and motor block, hemodynamic characteristics, assess duration of analgesia, assess sedation score and   side effects of addition of intrathecal dexmedetomidine 0.1ml(5 μg) or intravenous dexmedtomidine 0.5μg/kg to intrathecal 0.5% hyperbaric levobupivacaine.  


 
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