| CTRI Number |
CTRI/2021/10/037589 [Registered on: 26/10/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of two drug single or combination for prevention of nausea vomiting in caesarean |
|
Scientific Title of Study
|
Phenylepherine, ondensetron or a combination of both for prevention of intraoperative nausea and vomiting in patients undergoing lower segment caesarean section :a prospective ,double blind randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRATIBHA |
| Designation |
RESIDENT |
| Affiliation |
Rnt medical college |
| Address |
DEPARTMENT OF ANESTHESIA
RNT MEDICAL COLLEGE
MB HOSPITAL UDAIPUR
RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
8619094306 |
| Fax |
|
| Email |
PRAYADAV90@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIKRAM BEDI |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Rnt medical college |
| Address |
DEPARTMENT OF ANESTHESIA
RNT MEDICAL COLLEGE
MB HOSPITAL UDAIPUR
RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
vbedimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRATIBHA |
| Designation |
RESIDENT |
| Affiliation |
Rnt medical college |
| Address |
DEPARTMENT OF ANESTHESIA
RNT MEDICAL COLLEGE
MB HOSPITAL UDAIPUR
RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
8619094306 |
| Fax |
|
| Email |
PRAYADAV90@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANESTHESIA |
| Address |
RNT MEDICAL COLLEGE
MB HOSPITAL UDAIPUR
RAJASTHAN |
| 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 |
| PRATIBHA |
MAIN ZANANA OPERATION THEATER |
SECOUND FLOOR
MB HOSPITAL UDAIPUR
RAJASTHAN
Udaipur
RAJASTHAN |
8619094306
PRAYADAV90@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injection ondensetron |
Patients will receive normal saline @15 ml/hr +injection ondensetron 4 mg (2ml) |
| Comparator Agent |
phenylepherine ,2 ml normal saline(placebo) |
Patients will receive a prophylactic solution of 100microgm/ml of phenylepherine@15ml/hour (Dose 25microgm/min)+ 2 ml normal saline(placebo) |
| Intervention |
phenylepherine with bolus injection ondensetron |
Patients will receive a prophylactic solution of 100microgm/ml of phenylepherine @15ml/hour (Dose 25microgm/min) with bolus injection ondensetron 4 mg(2 ml) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
This study will be carried out in term pregnant female patients with singleton pregnancy, taken up for elective Caesarean Section under spinal anaesthesia for various indications like previous Caesarean Section, breech presentation, cephalopelvic disproportion, pregnancy following infertility treatment, cord around neck, non progression of labour |
|
| ExclusionCriteria |
| Details |
1.Patient refusal to participate in study
2.Emergency indication of Caesarean Section like antepartum haemorrhage, Placenta previa, abruptio placenta, fetal distress, obstructed labour, umbilical cord prolapse, preeclampsia, gestational diabetes, essential hypertension, more than two previous LSCS, history of PPH, multiple gestation.
3.Patients having contraindication for subarchnoid block.
4.Patient having associated systemic illness (hypo/hyperthyroidism, diabetic, neuromuscular disease ischemic/ valvular/ congenital heart disease, psychiatric, hematological disorder, SLE).
5.History of seizures, coma, neurological signs or symptoms (Eclampsia)
6.Any allergy to local anaesthetic or any drug.
H/o PONV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of IONV |
intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nausea score
Total consumption of phenylepherine in intraoperative period |
intraoperative |
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="195" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/10/2021 |
| Date of Study Completion (India) |
14/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
research conducted as a dissertation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intraoperative nausea and vomiting (IONV) is one of the commonest and most distressing complications in patients undergoing Lower Segment Caesarean Section under subarchnoid block((SAB).This is thought to be multi factorial in causation.Contributing factors include intraoperative hypotension,vagal hyperactivity,opioids use,utero tonic drugs and visceral pain. Therefore any intervention aimed at addressing one or more of these variable will be expected to decrease or abolish intraoperative nausea and vomiting. Aims and objectives
To determine whether combination of phenylepherine infusion with bolus ondensetron is more effective in prevention of intraoperative nausea vomiting,when compare to bolus ondensetron or phenylepherine infusion alone in patients undergoing Lower Segment Caesarean Section under subarchnoid block Primary outcome measured: 1.Incidence of IONV (each episode = 1 incidence) Secondary outcome 1. Nausea score 2. Total consumption of phenylepherine in intraoperative period
As the study period starts all consecutive parturient females posted for Caesarean Section will be enrolled for the study if they fulfil the inclusion criteria till 195 patient (65 in each group) will be completed. |