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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  
SGPGIMS 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 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  
Status 
Not Applicable 
 
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 
Details  ANY CO-MORBIDITY 
 
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.

 
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