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CTRI Number  CTRI/2023/01/049345 [Registered on: 31/01/2023] Trial Registered Prospectively
Last Modified On: 27/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   LEVOBUPIVACAINE AND BUPIVACAINE -A COMPARISON  
Scientific Title of Study   COMPARISON OF HEMODYNAMIC PARAMETERS AND QUALITY OF ANAESTHESIA BETWEEN LEVOBUPIVACAINE (0.5% HYPERBARIC) AND BUPIVACAINE (0.5% HYPERBARIC) DURING SPINAL ANAESTHESIA IN ELDERLY PATIENTS (AGE 60 to 90 YRS) UNDERGOING UROLOGICAL SURGERIES. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMrsSUREKHA SUDHIR CHAVAN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  BJ GOVERNMENT MEDICAL COLLEGE AND SASSOON GENERAL HOSPITAL 
Address  BJGMC AND SASSOON GENERAL HOSPITAL ,PUNE

Pune
MAHARASHTRA
411001
India 
Phone  9764901551  
Fax    
Email  surekhachavan659@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPALLAVI SAXENA 
Designation  PG RESIDENT 
Affiliation  BJ GOVERNMENT MEDICAL COLLEGE AND SASSOON GENERAL HOSPITAL 
Address  BJGMC AND SASSOON GENERAL HOSPITAL ,PUNE

Pune
MAHARASHTRA
411001
India 
Phone  9893445456  
Fax    
Email  itgetsboring@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrPALLAVI SAXENA 
Designation  PG RESIDENT 
Affiliation  BJ GOVERNMENT MEDICAL COLLEGE AND SASSOON GENERAL HOSPITAL 
Address  BJGMC AND SASSOON GENERAL HOSPITAL ,PUNE

Pune
MAHARASHTRA
411001
India 
Phone  9893445456  
Fax    
Email  itgetsboring@gmail.com  
 
Source of Monetary or Material Support  
BJ GMC AND SASSOON GENERAL HOSPITAL PUNE 411001 
DR PALLAVI SAXENA 
 
Primary Sponsor  
Name  PALLAVI SAXENA 
Address  BJ GOVERNMENT COLLEGE AND SASSOON GENERAL HOSPITAL PUNE 
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 
DR PALLAVI SAXENA  BJ GOVERNMENT MEDICAL COLLEGE AND SASSOON GENERAL HOSPITAL PUNE  DEPARTMENT OF ANAESTHESIA
Pune
MAHARASHTRA 		 9893445456

itgetsboring@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BJGMC AND SGH INSTITUTIONAL ETHICS COMMITTEE  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  BUPIVACAINE  Hyperbaric racemic bupivacaine is commonly used for spinal anesthesia due to its long duration of action and combined motor and sensory blockade. However, the use of hyperbaric racemic bupivacaine in spinal anesthesia has some drawbacks. It has a high propensity to cause hypotension and bradycardia following intrathecal injection, and there is potential for catastrophic cardiac toxicity due to the high affinity of bupivacaine to cardiac myocytes. dose-2.5ml of 0.5% hyperbaric bupivacaine frequency of route-intrathecal(subarachnoid block) duration of procedure-2hrs 
Comparator Agent  LEVOBUPIVACAINE  . Racemic bupivacaine is an equimolar mixture of dextro and levobupivacaine. Levobupivacaine has a lower affinity for cardiac sodium channels and greater plasma protein binding affinity compared with the dextro isomer thus reducing the risk of cardiotoxicity. Levobupivacaine also results in earlier motor recovery compared with racemic bupivacaine. These advantages make levobupivacaine an attractive alternative to racemic bupivacaine for spinal anesthesia. dose-2.5ml of 0.5% hyperbaric levobupivacaine frequency of route- intrathecal(sub arachnoid block) duration of procedure-2 hrs 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  • Age 60 to 90yrs
• height 145–180 cm
• weight 50–100 kg
• Both genders- male and female
• ASA grade I and ASA grade II
• Undergoing elective urological surgery of maximum 2 hrs of duration under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1.Age <60 yrs, > 90 yrs
2.Height<145cm, > 180 cm
3.Weight <50kgs, > 100 kg
4.ASA grade III and ASA grade IV
5.Patients with hepatic, cardiac, pulmonary, neuropsychiatric, renal or thyroid disease
6.Hypersensitivity to Bupivacaine or levobupivacaine.
7.Any contraindication to spinal anaesthesia ( local infection, spinal deformity, coagulopathy)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
This study will help us to determine whether there is any significant difference between the hemodynamic parameters changes in elderly patients (age 60 to 90 yrs) undergoing urological surgeries between levobupivacaine (0.5%hyperbaric)and bupivacaine(0.5%hyperbaric) and compare the onset and duration of sensory action and motor action between them.


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Secondary Outcome  
Outcome  TimePoints 
hemodynamic parameters (Pulse rate & Blood pressure). 2. quality of anesthesia (onset and duration of sensory and motor blockade),
3.adverse effects of levobupivacaine (0.5%hyperbaric) and bupivacaine (0.5%hyperbaric). 4.post operative cognitive status.
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Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   01/02/2023 
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="6"
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 anesthesia has been a popular anesthesia technique for short urological surgeries.. Hy­perbaric racemic bupivacaine is commonly used for spinal an­esthesia due to its long duration of action and combined motor and sensory blockade. However, the use of hyperbaric racemic bupivacaine in spinal anesthesia has some drawbacks. It has a high propensity to cause hypotension and bradycardia follow­ing intrathecal injection, and there is potential for catastrophic cardiac toxicity due to the high affinity of bupivacaine to cardiac myocytes. Racemic bupivacaine is an equimolar mixture of dextro and levobupivacaine. Levobupivacaine has a lower affinity for car­diac sodium channels and greater plasma protein binding affin­ity compared with the dextro isomer; thus, reducing the risk of cardio-toxicity [3–5].  Levobupivacaine also results in earlier motor recovery compared with racemic bupivacaine [8,9]. These advantages make levobupivacaine an attractive alternative to racemic bupivacaine for spinal anesthesia.

Urological surgeries are performed under regional anaesthesia with subarachnoid blockade on a wide variety of patients ranging from the young, physically fit to the elderly with multiple comorbidities.Most of the patients presenting for urological surgeries belong to the geriatric population having a coexisting cardiac,pulmonary condition,or some other comorbidities.

 
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