CTRI/2024/12/078466 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On:
20/11/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Surgical/Anesthesia
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A study comparing technique of spinal anesthesia injection for mothers undergoing cesarean operation to deliver babies- one by giving whole medicine at once and the other by giving half of the medicine at first and then giving the rest after 45 seconds and then check stability of blood pressure
Scientific Title of Study
A Comparison of the Effects of Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine (0.5%) in Spinal Anaesthesia for Parturients undergoing Elective Caesarean Section: A Randomised, Double Blind Study
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr BIJOY KUMAR BANDYOPADHYAY
Designation
PROFESSOR
Affiliation
Midnapore Medical College & Hospital
Address
Department of Anaesthesiology,
Midnapore Medical College & Hospital
Vidyasagar Road, Midnapore Town
Paschim Medinipur
Medinipur WEST BENGAL 721101 India
Phone
9332132242
Fax
Email
bjoybnrjee@gmail.com
Details of Contact Person Scientific Query
Name
Dr DEBALEENA JANA
Designation
Assistant Professor
Affiliation
Midnapore Medical College & Hospital
Address
Department of Anaesthesiology,
Midnapore Medical College & Hospital
Vidyasagar Road, Midnapore Town
Paschim Medinipur
Medinipur WEST BENGAL 721101 India
Phone
9477038017
Fax
Email
licimed@gmail.com
Details of Contact Person Public Query
Name
Dr SOMNATH DE
Designation
Junior Resident
Affiliation
Midnapore Medical College & Hospital
Address
Department of Anaesthesiology,
Midnapore Medical College & Hospital
Vidyasagar Road, Midnapore Town
Paschim Medinipur
Medinipur WEST BENGAL 721101 India
Phone
9475826623
Fax
Email
arunodaynight@gmail.com
Source of Monetary or Material Support
Office of the Principal, Midnapore Medical College & Hospital
Vidyasagar Road, Midnapore Town,
Paschim Medinipur, West Bengal
Pin-721101
Primary Sponsor
Name
Office of the Principal, Midnapore Medical College & Hospital
Address
Midnapore Medical College & Hospital
Vidyasagar Road, Midnapore Town
Paschim Medinipur
Pin-721101
West Bengal
Type of Sponsor
Government 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 SOMNATH DE
Midnapore Medical College & Hospital
Obstetric Operating Room, post operatve post natal ward,of Midnapore Medical College & Hospital
Department of Anesthesiology, Department of Obstetrics & Gynecology
Midnapore Medical College & Hospital
Vidyasagar Road, Midnapore Town
Paschim Medinipur Medinipur WEST BENGAL
9475826623
arunodaynight@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee, Midnapore Medical College
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: 1||Obstetrics,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Bolus spinal dose for hyperbaric bupivacaine
Group B parturients will be kept sitting for 45 seconds initially after insertion of needle with stylet insitu to prevent CSF loss and then they will receive bolus full dose of Hyperbaric bupivacaine (0.5%) by spinal anaesthesia. Total Dose will be calculated as 0.07mg/cm of height of the patient
Intervention
Fractionated spinal dose for hyperbaric bupivacaine
the group F parturients will receive Fractionated dose with half of Total calculated dose of Hyperbaric Bupivacaine (0.5%) administered initially followed by remaining half dose after 45 sec by spinal anesthesia. The time will be counted with the help of Stopwatch. For this 45 sec, the group F parturients will be kept in sitting position and the syringe will be kept attached to the Spinal needle. Total Dose will be calculated as 0.07mg/cm of height of the patient
Inclusion Criteria
Age From
18.00 Year(s)
Age To
35.00 Year(s)
Gender
Female
Details
1. Having ASA grade II .
2. Aged between 18 to 35 years.
3. Giving valid consents.
4. With singleton pregnancies undergoing Elective Caesarean Section under Spinal Anaesthesia.
ExclusionCriteria
Details
Parturients -
1. Not giving valid consent for Study or Spinal anaesthesia.
2. With severe cardio-respiratory disease.
3. With hepatic & renal disease.
4. With neurologic disorder or raised ICP.
5. With known endocrine disorder.
6. With psychiatric problems.
7. Having Coagulation disorder.
8. Having Spinal Deformity or Local infection at the site of injection.
9. With H/O allergy to study drugs
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Hemodynamic Stability in terms of Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial pressure
During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period)
After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
Secondary Outcome
Outcome
TimePoints
Respiratory rate
During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period)
After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
SpO2 %
During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period)
After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
ECG, ST changes
During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period)
After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
Level of sensory block and duration of sensory block
During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period)
After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
Degree of motor block and duration of motor block
During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period)
After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
Incidence of hypotension & Requirement of total dose of vasopressor
During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period)
After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
Incidence of side effects if any
During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period)
After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
Neonatal outcome by Apgar score
1 min,5 min after birth
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
Phase 4
Date of First Enrollment (India)
02/01/2025
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 Yet Recruiting
Recruitment Status of Trial (India)
Open to Recruitment
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
PROPOSED TOPIC OF RESEARCH: “A COMPARISON OF THE EFFECTS OF FRACTIONATED VERSUS BOLUS DOSE OF HYPERBARIC BUPIVACAINE (0.5%) IN SPINAL ANAESTHESIA FOR PARTURIENTS UNDERGOING ELECTIVE CAESAREAN SECTION : A RANDOMISED, DOUBLE BLIND STUDY.â€
OBJECTIVE OF PROPOSED RESEARCH:
To compare the effects of Fractionated and Bolus dose of Hyperbaric Bupivacaine (0.5%) on maternal hemodynamics following Spinal Anaesthesia in parturients undergoing elective caesarean section.
To assess characteristics of Block and observe the Duration of Analgesia.
BACKGROUND OF PRESENT STUDY:
Bolus dose of Hyperbaric Bupivacaine in spinal Anaesthesia has rapid onset of action but may trigger Maternal hypotension leading to decreased uteroplacental perfusion whereas fractionated dose with time interval can provide Maternal hemodynamic stability with extended duration of action for parturients undergoing elective caesarean section.
METHODOLOGY:
This study is institution based, prospective, randomized study on patients undergoing Elective Caesarean section under spinal anaesthesia in Obstetric OR of MMCH. In this study a total number of 100 patients ( Pregnant mothers – ASA II ) undergoing Elective Caesarean Section will be taken & randomized equally in two groups. Group A set of patients will get single bolus dose of Hyperbaric Bupivacaine (0.5%) ; whereas the group B patients will receive Fractionated dose with half of Total calculated dose of Hyperbaric Bupivacaine (0.5%) administered initially followed by remaining half dose after 45 sec. Incidence of Hypotension & Spinal Block characteristics will be monitored & assessed. Moreover the neonatal outcome will be assessed by APGAR Score at 1 min and 5 min.
EXPECTED OUTCOME: Patients receiving Fractionated dose of Hyperbaric Bupivacaine (0.5%) are expected to experience Hemodynamic stability with less chance of Hypotension and Dense sensory & motor block with extended duration of Analgesia in comparison to those receiving Bolus dose.