| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
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. |