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CTRI Number  CTRI/2024/07/071160 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing the effect of fentanyl and buprenorphine as an adjuvant to hyperbaric bupivacaine 0.5% to evaluate the hemodynamic parameters in infraumbilical surgery.  
Scientific Title of Study   Comparison of the effect of fentanyl and buprenorphine as an adjuvant to hyperbaric bupivacaine 0.5% in terms of hemodynamic parameters in infraumbilical surgery 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavya KJ 
Designation  Post Student 
Affiliation  Manipal college of Health Professions 
Address  Anaesthesia and Operation Theater Program, Manipal college of Health Professions, MAHE, Manipal,Udupi, Karnataka 576104
Manipal college of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India 
Phone  08970576847  
Fax    
Email  kavyagowda803@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Shweta Sinha 
Designation  Associate Professor 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesiology, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8879056117  
Fax    
Email  shweta.sinha@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Kavya KJ 
Designation  Post Student 
Affiliation  Manipal college of Health Professions 
Address  Anaesthesia and Operation Theater Program, Manipal college of Health Professions, MAHE, Manipal,Udupi, Karnataka 576104
Manipal college of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India 
Phone  08970576847  
Fax    
Email  kavyagowda803@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Hospital, MAHE, Manipal, Karnataka, India - 576104  
Manipal College Of Health Professions, MAHE, Manipal, Karnataka, India - 576104  
 
Primary Sponsor  
Name  Kavya KJ 
Address  Anaesthesia & Operation Theatre Technology Manipal College Of Health Professions MAHE Manipal Karnataka India - 576104 
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 Shweta Sinha  Kasturba Medical College and Hospital, Manipal   Department of Anaesthesiology Kasturba Medical College hospital MAHE Manipal Karnataka India 576104
Udupi
KARNATAKA 
8879056117

shweta.sinha@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee-2 (Student Research)  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical state â…  and â…¡ consenting for the procedure
Patients aged between 18-60 undergoing infraumbilical surgery  
 
ExclusionCriteria 
Details  -LSCS
-Infection
-Allergic to local anaesthetics
-Coagulation disorder
-Profound hypotension
-Fixed cardiac output status
-Indeterminate neurological disorders
-Increased intracranial pressur 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the frequency of bradycardia and hypotension between buprenorphine and fentanyl  5mins to 1hour post anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To find out how frequently side effects occur like pruritus & urine incontinence   3hours postoperatively 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   05/08/2024 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Upon the acquisition of CTRI registration, IRC, and IEC approval, participants will be given a description of the procedure and asked for their approval. This study will include participants undergoing elective infraumbilical surgery. Once in the operating room, the patient is connected to all the monitors. Under aseptic precautions, the patient is positioned in lateral recumbent position, the local anaesthetic drug hyperbaric bupivacaine 0.5% is taken. As fentanyl and buprenorphine are routinely used as an adjuvant during the administration of spinal anaesthesia, in this study we will be using it as per the discretion of the anaesthesiologist. One of the two adjuvant will be chosen as an additive to the local anesthetic, and the anaesthesiologist will administer spinal anaesthesia. After spinal anaesthesia, I will be monitoring the heart rate and blood pressure for every 2.5 minutes until the end of 30 minutes, and after 30 minutes until 1 hour every 5 minutes. If any itching or pruritus is present throughout this period, it is noted. The time from the spinal anaesthesia will be given until the patient is micturated will be noted. The data will be statistically analyzed.

 
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