Risk Factors Analysis for Clinical Important Postoperative Nausea and Vomiting

NCT ID: NCT06445920

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2024-06-15

Brief Summary

Postoperative nausea and vomiting (PONV) is a distressing and common complication after surgery. The concept of clinical important PONV (CI-PONV) assesses the impact of PONV on patient-reported outcomes. This research aims to conduct an analysis of the risk factors contributing to CI-PONV utilizing the least absolute shrinkage and selection operator (LASSO) and stepwise regression techniques. All 1154 patients participating in the FDP-PONV trial are included in this study and categorized into two groups: the CI-PONV group and the non-CI-PONV group. CI-PONV is defined as the occurrence of PONV with a simplified PONV impact scale score of 5 or higher within 24 hours after surgery. The LASSO method is employed to identify the most relevant variables from an initial set of 56 related variables and stepwise regression is used to further refine the selection of the ultimate predictors.A logistic regression model was developed based on the selected factors influencing CIPONV. A nomogram was developed as a tool for clinical application.

Detailed Description

Drawing from prior studies, we conducted a sample size calculation for a predictive model using the website https://mvansmeden.shinyapps.io/BeyondEPV/. By setting the number of candidate predictors to 9, the events fraction to 0.14, and the criterion value for rMPSE to 0.04, we determined that a minimum total sample size of 900 is required, with a minimally expected event per variable of 13.9. All patients were classified into either the CI-PONV group or the non-CI-PONV group. All 56 perioperative clinical features, encompassing baseline characteristics, preoperative conditions, and intraoperative information, were considered as potential predictive factors. In the quest to uncover potential predictive factors associated with CI-PONV, we employed the least absolute shrinkage and selection operator (LASSO) to sift through clinically significant variables. Subsequently, we utilized stepwise regression based on the Akaike Information Criterion (AIC) to further refine the selection of the ultimate predictors. Finally, a logistic regression model was developed based on the selected factors influencing CIPONV. The discrimination of the model was assessed by the ROCAUC and the goodness of fit of the model was evaluated using the Hosmer-Lemeshow test and calibration plots. A nomogram based on the logistic regression model output was developed as a tool for clinical application.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

CIPONV

The occurrence of PONV with the simplified PONV impact scale score of 5 or more.

No Intervention

Intervention Type: OTHER

No Intervention

Non-CIPONV

There was no occurrence of PONV, or if PONV occurred, the simplified PONV impact scale score was less than 5.

No Intervention

Intervention Type: OTHER

No Intervention

Interventions

No Intervention

No Intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

a) age between 18 and 75 years, b) having 3 or 4 Apfel risk factors, and c) scheduled to undergo laparoscopic gastrointestinal surgical procedures under general anesthesia.

Exclusion Criteria

a) American Society of Anesthesiologists (ASA) physical status greater than 3, b) severe hepatic dysfunction, c) contraindications to fosaprepitant, 5-HT3 receptor antagonist, or dexamethasone, d) preoperative use of medications known to have antiemetic properties, e) presence of mental disorders or inability to communicate, and f) pregnant or nursing women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhi-Nan Zheng

Attending doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhinan Zheng

Role: PRINCIPAL_INVESTIGATOR

The Sixth Affiliated Hospital, Sun Yat-sen University

Locations

Department of Anesthesia, The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

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Other Identifiers

2024ZSLYEC-201

Identifier Type: -

Identifier Source: org_study_id