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CTRI Number  CTRI/2022/12/048169 [Registered on: 15/12/2022] Trial Registered Prospectively
Last Modified On: 14/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARING THE EFFECTS OF TWO LOCAL ANAESTHESIA DRUGS FOR SPINAL ANESTHESIA  
Scientific Title of Study   COMPARING THE EFFECT OF INTRATHECAL DEXMEDETOMIDINE AS AN ADJUVANT TO HYPERBARIC BUPIVACAINE AND HYPERBARIC ROPIVACAINE IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERIES  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  TEJA PAGADALA  
Designation  JUNIOR RESIDENT 
Affiliation  M S RAMAIAH MEDICAL COLLEGE 
Address  DEPARTMENT OF ANESTHESIOLOGY, SECOND FLOOR, M S RAMAIAH MEDICAL COLLEGE, MSRIT POST, MSR NAGAR, BANGALORE

Bangalore
KARNATAKA
560054
India 
Phone  8951858818  
Fax    
Email  teja.pagadala599@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  GEETHA C R 
Designation  PROFESSOR AND HOD 
Affiliation  M S RAMAIAH MEDICAL COLLEGE 
Address  DEPARTMENT OF ANESTHESIOLOGY, SECOND FLOOR, M S RAMAIAH MEDICAL COLLEGE, MSRIT POST, MSR NAGAR, BANGALORE

Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  GEETHA C R 
Designation  PROFESSOR AND HOD 
Affiliation  M S RAMAIAH MEDICAL COLLEGE 
Address  DEPARTMENT OF ANESTHESIOLOGY, SECOND FLOOR, M S RAMAIAH MEDICAL COLLEGE, MSRIT POST, MSR NAGAR, BANGALORE

Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Source of Monetary or Material Support  
M S RAMAIAH MEDICAL COLLEGE, MSRIT POST, MSR NAGAR, BANGALORE 
 
Primary Sponsor  
Name  M S RAMAIAH MEDICAL COLLEGE 
Address  MSRIT POST MSR NAGAR BANGALORE 560054 
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 Geetha C R   M S RAMAIAH MEDICAL COLLEGE   Department of Anesthesiology, Second floor, M S Ramaiah Medical College Hospital
Bangalore
KARNATAKA 
9900482828

jaheedha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE M S RAMAIAH MEDICAL COLLEGE AND HOSPITALS  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, (2) ICD-10 Condition: S828||Other fractures of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sub-arachanoid block given with Hyperbaric Bupivacaine and Dexmedetomidine.  2.8ml of 0.5% Hyperbaric Bupivacaine + 0.1ml of 50mcg/ml Dexmedetomidine administered and the study parameters noted till the effect of the drug is regressed. 
Intervention  Sub-arachanoid block given with Hyperbaric Ropivacaine and Dexmedetomidine   2.8ml of 0.75% Hyperbaric Ropivacaine + 0.1ml of 50mcg/ml Dexmedetomidine administered and the study parameters noted till the effect of the drug is regressed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Elective lower limb Orthopedic surgeries.
American Society of Anesthesiologists Physical Status 1 and 2. 
 
ExclusionCriteria 
Details  Patients refusal to participate in the study.
Contraindications to Spinal Anaesthesia.
Pregnant women and lactating mothers.
Patient allergic to Opiods and Local Anaesthetic drugs.
Patient height <150cms. 
 
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 
To compare the effect on onset and duration of sensory block and onset and duration of motor block.  The block will be assessed at 1 minute interval for the first 10 minutes, every 5 minutes in the first hour, every 10 minutes till the regression of block. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect on hemodynamic changes in both the groups like hypotension, bradycardia and side effects such as nausea, vomiting, pruritius and shivering.  Hemodynamic parameters measured at every 2 minute intervals for the first 10
minutes followed by 5 minute intervals for the next 20 minutes and at 10 minute intervals till the end of the surgery. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/12/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [teja.pagadala599@gmail.com].

  6. For how long will this data be available start date provided 22-04-2024 and end date provided 22-04-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Subarachnoid block is a popular mode of anaesthesia for lower abdominal as well as lower limb surgeries. It is not associated with disadvantages of general anaesthesia like airway manipulation, usage of multiple drugs, additional supplementary analgesics, postoperative nausea and vomiting. Local anaesthetic drugs such Bupivacaine, Levobupivacaine and Ropivacaine are commonly used for spinal anaesthesia, with Bupivacaine being most common. The advantages being, early onset and prolonged duration of sensory blockade.
Ropivacaine, a newer amide local anaesthetic has many similar properties with Bupivacaine, but with lesser incidence of cardiovascular and central nervous system toxicity. Ropivacaine also has a faster recovery from motor block. Adding adjuvants like Morphine, Fentanyl, Dexmedetomidine to the local anaesthetic increases the duration of action, increases the density of block, decreases the dose requirement thereby also reducing the risk of complications. Fentanyl and Morphine are known to cause side effects like nausea, vomiting and pruritus.
Intrathecal Dexmedetomidine, an alpha 2 receptor agonist as an adjuvant had favourable outcomes. Addition of Dexmedetomidine to Ropivacaine and Bupivacaine for spinal
anaesthesia in parturients has shown to hasten the onset of sensory and motor block, prolong the time of sensory block, improve muscle relaxation, improve intraoperative somatovisceral sensory block characteristics and postoperative analgesia, decrease shivering, with minimal hemodynamic and other side effects.
There is paucity of literature comparing the effect of Dexmedetomidine as an adjuvant to Bupivacaine and Ropivacaine on block characteristics. Hence, the present study has been designed to compare the effects of Dexmedetomidine as an adjuvant with 0.5% hyperbaric Bupivacaine and 0.75% hyperbaric Ropivacaine on onset, duration and recovery from sensory and motor blockade in spinal anaesthesia and also on hemodynamic effect.
 
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