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CTRI Number  CTRI/2021/03/032416 [Registered on: 30/03/2021] Trial Registered Prospectively
Last Modified On: 28/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Use of preoperative anxiety sensitivity index questionnaire in predicting postoperative nausea and vomiting. 
Scientific Title of Study   Preoperative anxiety sensitivity index in predicting postoperative nausea and vomiting : 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  Akshita Niranjan 
Designation  PG Resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesia 2nd Floor MS Ramaiah Hospital New BEL Road

Bangalore
KARNATAKA
560054
India 
Phone  9900049181  
Fax    
Email  akshitaniranjan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manjunath A C 
Designation  Associate Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesia 2nd Floor MS Ramaiah Hospital New BEL Road

Bangalore
KARNATAKA
560054
India 
Phone  8310544067  
Fax    
Email  manjumac5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manjunath A C 
Designation  Associate Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesia 2nd Floor MS Ramaiah Hospital New BEL Road

Bangalore
KARNATAKA
560054
India 
Phone  8310544067  
Fax    
Email  manjumac5@gmail.com  
 
Source of Monetary or Material Support  
M S Ramaiah Medical College New BEL Road Bangalore 
 
Primary Sponsor  
Name  M S Ramaiah Medical College 
Address  New BEL Road Bangalore 560054 
Type of Sponsor  Private medical college 
 
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 
Manjunath A C  M S Ramaiah Medical College Hospital  Department of Anaesthesia 2nd Floor M S Ramaiah Hospital New BEL Road
Bangalore
KARNATAKA 
8310544067

manjumac5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee M S Ramaiah Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Patients presenting for elective surgery 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Non Smokers
Scheduled to undergo elective surgery
ASA-PS 1 and 2 
 
ExclusionCriteria 
Details  Male patients
Smokers
Patients with history of psychiatric illness
Emergency surgeries
History of substance abuse
Regional anaesthesia techniques
Intracranial interventions
Planned TIVA 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate preoperative anxiety sensitivity score using Anxiety sensitivity index 3 questionnaire and postoperative nausea and vomiting in the first 24hours after surgery  To evaluate preoperative anxiety sensitivity score using Anxiety sensitivity index 3 questionnaire and postoperative nausea and vomiting in the first 24hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="373"
Sample Size from India="373" 
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)   01/04/2021 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
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 - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  by personal email communication

  6. For how long will this data be available start date provided 01-08-2023 and end date provided 01-08-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Postoperative nausea and vomiting (PONV) is an unpleasant side effect for patients undergoing surgery under general anaesthesia and must be given equal importance as the treatment of postoperative pain. This symptom can affect the quality of recovery after surgery. In spite of giving the patients prophylactic antiemetic treatment before or during surgery, the incidence of PONV is still high. There are multiple established independent risk factors for PONV such as female sex, history of PONV or motion sickness, non-smoking status and age. Anaesthesia and surgery related predictors, such as use of volatile anaesthetic agents or postoperative use of opioids and the type of surgery are also established risk factors. The frequently used Apfel- Score includes four risk factors (female sex, non-smoking status, motion sickness or history of PONV and the expected postoperative administration of opioids). In addition to it, studies have suggested preoperative anxiety could also be a predictor of PONV. Although the Apfel score and other scoring systems are well established and often used to define standardised procedures for a risk based antiemetic strategy for patients with an increased risk for PONV, about 30% of patients still suffer from PONV.

The influence of psychological factors such as anxiety as a cause of PONV has not been explored sufficiently so far. Anxiety sensitivity can be described as the ‘fear of fear’ or the fear of anxiety. Anxiety sensitivity is a psychological construct which describes the tendency of a person to fear the sensations caused by anxiety (e.g. those sensations following activation of the sympathetic nervous system: tachycardia, palpitations, dyspnoea, sweating or trembling) because of a belief that these symptoms can have negative consequences. Anxiety sensitivity is believed to intensify states of fear and anxiety.

A recent study conducted on patients with increased risk of PONV i.e. female non-smokers undergoing elective surgery under general anaesthesia has shown that anxiety sensitivity can predict the risk of PONV. This study is undertaken to predict PONV by using anxiety sensitivity index.

 

 

 
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