CTRI Number |
CTRI/2021/03/032262 [Registered on: 24/03/2021] Trial Registered Prospectively |
Last Modified On: |
22/04/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Ondansetron and its effect on fluid administration in preventing post spinal hypotension in pregnant females undergoing elective cesarean section |
Scientific Title of Study
|
Comparative Evaluation of the Effect of Intravenous Ondansetron ON Crystalloid Fluid Loading Regimens for Preventing Spinal Anaesthesia Induced Hypotension during cesarean delivery. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
vansh priya |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
SGPGIMS |
Address |
Department of anaesthesia
SGPGIMS RAIBAREILLY ROAD Lucknow UTTAR PRADESH 226014 India |
Phone |
08005385095 |
Fax |
|
Email |
vanshkhr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
vansh priya |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
SGPGIMS |
Address |
Department of Anaesthesia
SGPGIMS RAIBAREILLY ROAD Lucknow UTTAR PRADESH 226014 India |
Phone |
08005385095 |
Fax |
|
Email |
vanshkhr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
vansh priya |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
SGPGIMS |
Address |
Department of Anaesthesia
SGPGIMS RAIBAREILLY ROAD Lucknow UTTAR PRADESH 226014 India |
Phone |
08005385095 |
Fax |
|
Email |
vanshkhr@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
NIL |
Address |
NIL |
Type of Sponsor |
Other [NIL] |
|
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 VANSH PRIYA |
sanjay gandhi post graduate institute of medical sciences |
Department of Anaesthesia Lucknow UTTAR PRADESH |
05224105340
vanshkhr@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC, SGPGIMS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
CO-LOAD CRYSTALLOID |
500 ml of Ringers lactate will be administered as co-load over 10 minutes, as soon as CSF appears during administration of spinal anaesthesia and 8 mg of ONDANSETRON will be administered i.v, 5 minutes prior to administration of spinal anaesthesia. |
Comparator Agent |
COLOAD WITH CRYSTALLOID |
500 ml of Ringers lactate will be administered as co-load over 10 minutes, as soon as CSF appears during administration of spinal anaesthesia. |
Intervention |
CRYSTALLOID PRELOAD |
500 ml of Ringers lactate will be administered as preload over 10 minutes, 10 minutes prior to administration of spinal anaesthesia and 8 mg of ONDANSETRON will be administered i.v, 5 minutes prior to administration of spinal anaesthesia. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
ASA II
SINGLETON UNCOMPLICATIED PREGNANCY
NON LABORING
ELECTIVE CESAREAN DELIVERY
SPINAL ANAESTHESIA |
|
ExclusionCriteria |
|
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 |
INCIDENCE AND SEVERITY OF POST SPINAL HYPOTENSION |
post spinal |
|
Secondary Outcome
|
Outcome |
TimePoints |
PHENYLEPHRINE CONSUMED
pH and Base excess of new born |
immediately after delivery |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
29/03/2021 |
Date of Study Completion (India) |
12/01/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
12/01/2023 |
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
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Introduction Spinal anaesthesia is preferred anaesthesia technique for elective caesarean section. The main disadvantage of spinal anaesthesia is maternal hypotension, incidence of which is around 90% of women and can cause dizziness, nausea and vomiting, fetal acidosis and in severe cases fetal bradycardia and cardiovascular collapse. The Bezold–Jarisch reflex has been proposed as a mechanism for the accompanying bradycardia and hypotension post spinal anaesthesia. This reflex is mediated by serotonin receptors (5-HT3 subtype). Ondansetron, a potent 5-HT3 receptor antagonist commonly used as an antiemetic drug, is potentially useful to attenuate this response. Therefore we have designed this study to test our hypothesis that prophylactic ondansetron (8 mg) administered 5 minutes prior to spinal anaesthesia induction would result in greater attenuation of post spinal hypotension when combined with 500 ml co-load of ringer’s lactate. Primary aim will be to assess the severity of hypotension amongst the three groups while secondary aim will be to assess total phenylephrine consumption, neonatal cord blood base excess. Material methods After obtaining ethics committee approval and a written informed consent, this study will be performed in one hundred twenty (n=40) American Society of Anesthesiologists (ASA) physical status II patients, women aged 18 yr or older, BMI less than 40, height between 150-180 cm, non-laboring, at term with singleton uncomplicated pregnancies, scheduled for elective caesarean delivery under spinal anaesthesia. Patients will be randomised and allotted one of the three groups using opaque sealed envelope method. Patients in group A will be administered 500 ml of ringer’s lactate as pre-load infused over 10 minutes in O.R, 10 minutes prior to administration of spinal anaesthesia. as soon as CSF appears during administration of spinal anaesthesia. Patients in group B will be administered 500 ml of ringer’s lactate as co-load over 10 minutes as soon as CSF appears during administration of spinal anaesthesia. Patients in group C will be administered 500 ml of ringer’s lactate as co-load over 10 minutes as soon as CSF appears during administration of spinal anaesthesia. Patients in groups A and B will be administered 8 mg of ondansetron i.v, over one minute, five minutes before administration of spinal anaesthesia while in group C, 8 mg of ondansetron will be administered prior to completion of caesarean section. SBP, diastolic blood pressures (DBP), mean arterial pressures (MAP), HR, and SpO2 values will be monitored throughout the operation and recorded intraoperatively with 1-min intervals till baby is delivered and thereafter every 3 minutes until the end of the operation. A HR lower than 60 beats/min will be defined as bradycardia and will be treated with 0.5 mg of atropine sulphate, intravenously. Hypotension, defined as SBP less than 80% of baseline (prenatal), will be treated with 100 μg phenylephrine i.v bolus. The results will be presented as mean ± standard deviation, median (range) or n (%) as appropriate. Patient’s characteristics, onset, duration and severity of hypotension, cord blood base excess among the groups will be compared using one-way analysis of variance followed by Bonferroni correction. For haemodynamic changes within the groups, repeated measures analysis of variance followed by post hoc Bonferroni tests will be performed. Apgar scores and phenylephrine doses will be analysed by Kruskal-Wallis and Mann- Whitney U tests. The incidence of hypotension and adverse effects will be analysed using chi-square test and Fisher’s exact test. A P value <0.05 will be considered statistically significant. |