Association Between Preoperative Metformin Exposure and Postoperative Nausea and Vomiting in Patients Undergoing General Anesthesia

NCT07244575 | Recruiting DMC

• 1 other identifier: E2025278
• Study Type: observational
• Target: 909
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to investigate the potential effects of metformin on postoperative nausea and vomiting (PONV) in patients undergoing surgery under general anesthesia. The primary research question is: Does preoperative metformin exposure influence the incidence or severity of PONV in patients undergoing general anesthesia? Patients who are already prescribed metformin as part of their routine medical management will be compared with those not taking metformin. Data on PONV occurrence, severity, and recovery outcomes will be collected through structured postoperative surveys administered after surgery.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• The incidence of PONV during 0-120 postoperative hours

  PONV is defined as the occurrence of any of the following symptoms: nausea, retching, or vomiting

  During 0-120 hour after surgery

Secondary Outcomes (9)

• The incidence PONV during 0-24 hour after surgery

  During 0-24 hour after surgery

• The incidence PONV during 24-120 hour after surgery

  During 24-120 hour after surgery

• The total severity of PONV during 0-120 hour after surgery

  During 0-120 hour after surgery

• The severity of PONV during 0-24 hour after surgery

  During 0-24 hour after surgery

• The severity of PONV during 24-120 hour after surgery

  During 24-120 hour after surgery

Other Outcomes (5)

• Quality of recovery at 30-day after surgery

  At 30-day after surgery

• Incidence and grade of major postoperative complications

  During 30 day after surgery

• PONV-related factors in the blood or urine.

  from preoperative to postoperative

Study Arms (2)

Exposure group

Patients are already prescribed metformin before surgery

The non-exposure group

Patients are not prescribed metformin before surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for surgery under general anesthesia with tracheal intubation

You may qualify if:

• Voluntarily sign the informed consent form;
• Age ≥ 18 years;
• Patients who require surgical treatment under endotracheal intubation with general anesthesia as determined by the treating physician.

You may not qualify if:

• Emergency surgery;
• Currently taking medications with established antiemetic effects (e.g., corticosteroids, antipsychotics) due to underlying medical conditions;
• Cognitive impairment or psychiatric disorders that preclude cooperation with questionnaire assessments;
• Anticipated inability to extubate the tracheal tube postoperatively, which would interfere with outcome assessment;
• Presence of nausea and/or vomiting prior to surgery.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (15)

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Biospecimen

Retention: SAMPLES WITH DNA

blood samples and urine samples

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Yang Zhao, Dr

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Zhao, Doctor

CONTACT

0086-02038254070; zhaoy47@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available after the manuscript is published.
• Access Criteria: The request for the analytic code shall be sent to Prof. Yang Zhao, Email-address: zhaoy47@mail.sysu.edu.cn

Locations

CN (1)