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NCT05014737 Clinical Trial

External Validation of the Apfel Risk Score and Koivuranta Score to Predict Postoperative Nausea and Vomiting in Patients With Liver Cancer

Postoperative Nausea and Vomiting Clinical Trial

Official title:
External Validation of Two Models to Predict Postoperative Nausea and Vomiting (PONV) in Patients With Liver Cancer in Chinese Hospital Setting

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05014737
Other study ID # B2020-347
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date May 1, 2022

Study information
Verified date August 2021
Source Shanghai Zhongshan Hospital
Contact Yuxia Zhang, phd
Phone 13816881925
Email zhang.yx@aliyun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Postoperative nausea and vomiting (PONV) is a common complication among surgical patients. The incidence ranging from 20% to 50% depends on different population studied. Clinical practice guidelines recommend routine PONV screening before surgery using the Apfel simplified risk score OR Koivuranta score. However, these two scores haven't been translated into Chinese version and tested for psychometric qualities. Therefore, this study aim to externally validate two PONV prediction models in the Chinese hospital setting for PONV assessment.

Recruitment information / eligibility
Status Recruiting
Enrollment 214
Est. completion date May 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - patients receiving hepatobiliary surgery Exclusion Criteria: - patients receiving chemothreapy;patients with cognitive disorders; patients unwilling to participate.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
this is an abservational study and no intervention will be involved

Locations
Country Name City State
China Shanghai Zhongshan Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative nausea and vomiting Postoperative nausea will be assessed at 24 hours after surgery on an 11-point numeric scale (0 -10) by a trained nurse. Patients will be asked to respond to the question, "Have you felt nauseated since your discharge from the postanesthetic care unit and if so, what would be the average level of nausea you have felt until now on a 0 to 10 scale?". Patients will be considered nauseated if postoperative nausea is reported to be greater than zero on the 11-point scale with the question. For the same intervals the number of episodes of postoperative vomiting will be recorded. Again, patients will be considered to have vomited if postoperative vomiting occurs at least once within 24 hours. Patients who have either postoperative nausea or postoperative vomiting in 24h will be considered to have PONV. 24 hours after surgery
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Completed NCT00734929 - Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy Phase 4