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CTRI Number  CTRI/2022/11/047657 [Registered on: 25/11/2022] Trial Registered Prospectively
Last Modified On: 18/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Incidence of postoperative nausea and vomiting 
Scientific Title of Study   Incidence and correlating factors of postoperative Nausea and Vomiting during the modern days of balanced anaesthesia - a prospective observational study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AJITH G 
Designation  POST GRADUATE STUDENT 
Affiliation  SRM MCH AND RC, SRMIST 
Address  PG STUDENT MSC ANAESTHESIA TECHNOLOGY DEPARTMENT OF ANAESTHESIOLOGY SRM MEDICAL COLLEGE AND HOSPITAL SRMIST SRM NAGR KATTANGULATHUR CHENGALPATTU DISTRICT

Kancheepuram
TAMIL NADU
603203
India 
Phone    
Fax    
Email  davidajith31@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MIRUNALINI G 
Designation  ASSISTANT PROFESSOR 
Affiliation  SRM MCH RC, SRMIST 
Address  DEPARTMENT OF ANAESTHESIOLOGY SRM MEDICAL COLLEGE AND HOSPITAL SRMIST SRM NAGR KATTANGULATHUR CHENGALPATTU DISTRICT

Kancheepuram
TAMIL NADU
603203
India 
Phone  9486131643  
Fax    
Email  mirunalini.gunaseelan@gmail.com  
 
Details of Contact Person
Public Query  
Name  MIRUNALINI G 
Designation  ASSISTANT PROFESSOR 
Affiliation  SRM MCH RC, SRMIST 
Address  DEPARTMENT OF ANAESTHESIOLOGY SRM MEDICAL COLLEGE AND HOSPITAL SRMIST SRM NAGR KATTANGULATHUR CHENGALPATTU DISTRICT

Kancheepuram
TAMIL NADU
603203
India 
Phone  9486131643  
Fax    
Email  mirunalini.gunaseelan@gmail.com  
 
Source of Monetary or Material Support  
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER 
 
Primary Sponsor  
Name  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER 
Address  SRM MCH AND RC SRMIST SRM NAGAR KATTANKULATHUR CHENGALPATTU DISTRICT TAMIL NADU 603 203 
Type of Sponsor  Research institution and hospital 
 
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 
MIRUNALINIG  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER  ROOM NO.219, A BLOCK, SECOND FLOOR, DEPARTMENT OF ANAESTHESIOLOGY.
Kancheepuram
TAMIL NADU 		 9496131643

mirunalini.gunaseelan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R112||Nausea with vomiting, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA 
 
ExclusionCriteria 
Details  NOT CONSENTING PATIENTS 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
INCIDENCE OF POSTOPERATIVE NAUSEA AND VOMITING  24 HOURS AFTER SURGERY 
 
Secondary Outcome  
Outcome  TimePoints 
RISK FACTORS ASSOCIATED WITH POSTOPERATIVE NAUSEA AND VOMITING  24 HOURS AFTER SURGERY 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   01/12/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mirunalini.gunaseelan@gmail.com].

  6. For how long will this data be available start date provided 01-05-2023 and end date provided 30-04-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The patients who qualify as per the selection criteria will be given a clear explanation regarding the anaesthesia procedure in their vernacular language. A written consent will be obtained in each case. The patients who have undergone surgery in general anaesthesia will be reviewed after 24 hours of surgery. Data will be collected by interviewing the patient, attending staff nurse and also on examining the case  record

 

The following data will be collected

1.Body mass index

2.H/O of smoking

3.H/O motion sickness

4.H/O PONV

5.Type of surgery

6.Duration of surgery

7.Intra operative Anaesthetic drugs used

8.Pulse rate, BP and oxygen saturation (SpO2) prior to the induction

9.Mean Intraoperative pulse rate, BP, and SpO2  throughout the surgery

10.Post operative opioids

11.Post operative pain  using VAS SCORE

 

For the purpose of the study, an episode of PONV denotes a distinct spell of nausea, retching (an involuntary attempt to vomit but not actually productive of stomach contents), or vomiting (actual expulsion of stomach contents). Patients with complain of nausea, vomiting, or retching were administered injection prochlorperazine 12.5 mg as rescue antiemetic.

 
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