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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy Patients presenting for elective surgery |
|
Intervention / Comparator Agent
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - by personal email communication
- 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.
- 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. |