CTRI Number |
CTRI/2021/10/037039 [Registered on: 01/10/2021] Trial Registered Prospectively |
Last Modified On: |
30/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare the effect of consecutive versus premixed administration of hyperbaric bupivacaine and fentanyl in neuraxial anaesthesia for caesarean section |
Scientific Title of Study
|
A comparative study of consecutive with premixed administration of hyperbaric bupivacaine and fentanyl in neuraxial anaesthesia for caesarean section |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Seema Jindal |
Designation |
Associate Professor, Department of Anaesthesiology |
Affiliation |
Guru Gobind Singh Medical College And Hospital, Faridkot |
Address |
Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot
Faridkot PUNJAB 151203 India |
Phone |
9646050485 |
Fax |
|
Email |
jindalseema77@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Seema Jindal |
Designation |
Associate Professor, Department of Anaesthesiology |
Affiliation |
Guru Gobind Singh Medical College And Hospital, Faridkot |
Address |
Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot
Faridkot PUNJAB 151203 India |
Phone |
9646050485 |
Fax |
|
Email |
jindalseema77@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shveta Goyal |
Designation |
Junior Resident MD Anaesthesiology |
Affiliation |
Guru Gobind Singh Medical College And Hospital, Faridkot |
Address |
Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot
Faridkot PUNJAB 151203 India |
Phone |
7986192347 |
Fax |
|
Email |
shvetagoyal99@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology |
Address |
Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot |
Type of Sponsor |
Government medical college |
|
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 Seema Jindal |
Guru Gobind Singh Medical College And Hospital, Faridkot |
Department of Anesthesiology Faridkot PUNJAB |
9646050485
jindalseema77@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee of GGS Medical College And Hospital, Faridkot |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O80-O82||Encounter for delivery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Consecutive versus premixed administration of hyperbaric bupivacaine and fentanyl |
In one technique, patients will receive hyperbaric bupivacaine and fentanyl in premixed form in single syringe in neuraxial anaesthesia.
In other techniques, patients will receive hyperbaric bupivacaine and fentanyl consecutively in separate syringes in neuraxial anaesthesia for caesarean section. |
Intervention |
Hyperbaric bupivacaine and fentanyl |
Time of onset of sensory block will be assesed after administration of hyperbaric bupivacaine and fentanyl in neuraxial anaesthesia for caesarean section. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
•Patients belonging to American Society of Anesthesiologist Grade I and II
•Parturients aged 18-35 years undergoing caesarean section
|
|
ExclusionCriteria |
Details |
•Parturients with complicated pregnancy as preeclampsia, pregnancy induced hypertension, gestational diabetes, abnormal placenta (placenta praevia), multiple gestation
•BMI greater than 35 or less than 22 Kg/m2
•Height less than 150 cm and greater than 170 cm
•Gestational age less than 36 weeks
•Major systemic diseases (cardiac, renal, liver)
•Having allergy to drugs used in the study
•Patients having neuropathies
•Having contraindications for spinal anaesthesia
|
|
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 |
•To study the effect of consecutive administration of hyperbaric bupivacaine followed by fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
•To study the effect of consecutive administration of fentanyl followed by hyperbaric bupivacaine on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
•To study the effect of premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
•To compare the effect of consecutive with premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
|
Time of onset of sensory block will be assessed. Segmental sensory level of anaesthesia will be assessed by pts response to pinprick every 2 min. till 20 min. |
|
Secondary Outcome
|
Outcome |
TimePoints |
•Time of onset of motor block
•Time of regression of sensory block.
•Time of regression of motor block.
|
Time of onset of motor block will be assessed every 5 min. for 20 min.
Time of regression of sensory and motor block will be assessed.
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
11/10/2021 |
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) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Introduction: Spinal anaesthesia is the preferred technique for caesarean section being easy to perform, cost effective, having higher efficiency, causing lesser neonatal depression and decreased risk of aspiration of gastric contents. Hyperbaric bupivacaine is commonly used local anaesthetic for spinal anaesthesia in caesarean section .Local anaesthetics in neuraxial anaesthesia block motor and sensory system. They also block sympathetic nervous system which causes unwanted physiological alterations. Certain adjuvants like fentanyl are used to minimize the side effects of local anaesthetics by bringing down their volume. Addition of fentanyl to hyperbaric bupivacaine may alter the density of the mixture and affect the spread of hyperbaric bupivacaine. If both drugs are injected separately in different syringes, it may minimize the effect of changes in densities and pH of both drugs. Aims and Objectives: - To study the effect of consecutive administration of hyperbaric bupivacaine followed by fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
- To study the effect of consecutive administration of fentanyl followed by hyperbaric bupivacaine on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
- To study the effect of premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
- To compare the effect of consecutive with premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
Materials and Methods:Study will be conducted in the Department of Anaesthesiology at Guru Gobind Singh Medical College and Hospital, Faridkot. Inclusion criteria: (1) Patients belonging to American Society of Anaesthesiologist Grade I and II. (2) Parturients aged 18-35 years undergoing caesarean section. Exclusion criteria: (1) Parturients with complicated pregnancy as preeclampsia, pregnancy induced hypertension, gestational diabetes, abnormal placenta (placenta praevia), multiple gestation. (2) BMI greater than 35 or less than 22 Kg/m2. (3) Height less than 150 cm. and greater than 170 cm. (4) Gestational age less than 36 weeks. (5) Major systemic diseases (cardiac, renal, liver). (6) Having allergy to drugs used in the study. (7) Patients having neuropathies. (8) Having contraindications for spinal anaesthesia. Methodology:A total of 120 patients divided into 3 groups (40 each) i.e. Group A: Patients receiving 2.0 ml of 0.5% hyperbaric bupivacaine followed by 25 mcg of fentanyl through separate 3 ml syringes, Group B: Patients receiving 25 mcg of fentanyl followed by 2.0 ml of 0.5% hyperbaric bupivacaine through separate 3 ml syringes, Group C: Patients receiving 2.0 ml of 0.5 % hyperbaric bupivacaine + 25 mcg of fentanyl premixed in a 3 ml syringe. Parameters assessed:Onset of sensory block in 3 groups, Onset of motor block in 3 groups, Time of regression of sensory block, Time of regression of motor block, Vital parameters of patient like pulse rate, blood pressure, SPO2, frequency of hypotension, need for vasopressors, Requirement of rescue analgesia, Neonatal outcome in the form of Apgar score, Patient satisfaction score. |