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CTRI Number  CTRI/2024/02/063018 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Evaluate the Effects of continuous Versus Premixed Administration of Hyperbaric Ropivacaine 0.75% and Fentanyl in patients planned for Elective Urological Surgery Under Spinal Anaesthesia 
Scientific Title of Study   A Randomized Comparative Study to Evaluate the Effects of Successional Versus Premixed Administration of Intrathecal Hyperbaric Ropivacaine 0.75% and Fentanyl in patients scheduled for Elective Urological Surgery Under Spinal Anaesthesia 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tania Ghosh 
Designation  Anaesthesia Resident 
Affiliation  Maharishi Markandeshwar university 
Address  Department Of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana,Ambala
mullana,Ambala,Haryana
Ambala
HARYANA
133207
India 
Phone  8697684533  
Fax    
Email  cutetanu.ghosh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sapna Bansal 
Designation  Professor 
Affiliation  MM Institute of Medical Sciences and Research 
Address  Department Of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana,Ambala

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sapna Bansal 
Designation  Professor 
Affiliation  MM Institute of Medical Sciences and Research 
Address  Department Of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana,Ambala

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala 
 
Primary Sponsor  
Name  Dr Sapna Bansal Professor Department of Anaesthesiology 
Address  MM Institute of Medical Sciences and Research Centre, Mullana, Ambala 
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 Tania Ghosh  MM Institute of Medical Sciences and Research Centre  Department of Anaesthesiology,2nd floor,old Building,MM Institute of Medical Sciences and Research, Mullana, Ambala, Haryana
Ambala
HARYANA 		 08697684533

cutetanu.ghosh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,MMIMSR,Mullana,Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  posted for elective urological surgery 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Premixed Spinal Anaesthesia  Group P: premixed 0.75% hyperbaric ropivacaine 2.5ml and 0.5ml of fentanyl in a single 5.0ml syringe  
Comparator Agent  Successional administration of Hyperbaric Ropivacaine and fentanyl  Group S: 0.5ml of fentanyl in a 2.0ml Syringe followed by 0.75% hyperbaric ropivacaine 2.5ml in a 5.0ml syringe. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  either gender of age 18-55years and ASA I and ASA II status scheduled for elective urological surgery under spinal anaesthesia 
 
ExclusionCriteria 
Details  1. Negative consent by the patient
2. contraindication for spinal anaesthesia
( such as coagulopathy, infection at injection site, hypotension ,disease or deformity of spine)
3.psychiatric patient
4. ASA status III/IV
5. known sensitivity to drug 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the onset ,duration and highest level of sensory block along with degree and duration of motor block  intraoperative period after spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To study the hemodynamic changes occuring among the two study groups after administration of the respective drugs

To study the side effects 		 intraoperative period after spinal anaesthesia  
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) 17/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 12-02-2024 and end date provided 11-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Now a days, spinal anaesthesia is being utilized in many operations which are below the umbilicus as being cost effective, associated with few respiratory complications, the airway is not manipulated which reduces the risk of airway obstruction or aspiration of gastric components, blood loss is less intraoperatively comparative to same operation being conducted under general anaesthesia. The introduction of Hyperbaric Ropivacaine (0.75%) has revolutionized the safety profile of local anaesthetic agents. Ropivacaine is the pure S-enantiomer which is associated decreased cardiotoxicity as compared to Bupivacaine. Other advantages of Ropivacaine are that it produces sensorimotor differential blockade with early recovery from motor blockade and thus leading to early ambulation of patient and also has decreased central nervous system toxicity.  Blending opioids with hyperbaric bupivacaine affects the amount of drug that spreads into the intrathecal space because it changes the density of the hyperbaric solution.

. At 37°C, cerebrospinal fluid (CSF) has a density of 1.00059 g/ml. Fentanyl has a baricity of 0.99410 while hyperbaric bupivacaine has a baricity of 1.02360. After annexing Fentanyl(20mcg) to the identical syringe as local anaesthetic, baricity of the solution becomes 1.018502. A change in a solution’s baricity of 0.0006 can change how local anaesthesia spreads in the cerebrospinal fluid (CSF). Hyperbaric solutions improve intraoperative physiological state, lengthen the period of impact, and become more easy to predict, with greater unfold within the direction of gravity and less inter-patient variability, provide with stable haemodynamic and prolonged postoperative analgesia. [15] The specific gravity of Ropivacaine hydrochloride in dextrose injection is between 1.025 and 1.035 at 250 C and about 1.03 at 370 C which is more comparative to Bupivacaine. Though the Fentanyl has been used extensively premixed with hyperbaric bupivacaine for spinal anaesthesia, there is paucity of literature on clinical effects and understanding of mechanism of influence of fentanyl on subarachnoid block produced by hyperbaric ropivacaine when administered separately by another syringe, either before or after ropivacaine. Correlating with the available literatures on premixed versus sequential administration of intrathecal fentanyl and bupivacaine - The present study will be done to evaluate the effects of successional versus premixed administration of intrathecal hyperbaric ropivacaine and fentanyl in spinal anaesthesia undergoing elective urological surgery.


 
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