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Association Between Preoperative Metformin Exposure and Postoperative Nausea and Vomiting in Patients Undergoing General Anesthesia (Met-PONV)

Sun Yat-sen University logo

Sun Yat-sen University

Status

Enrolling

Conditions

Postoperative Nausea and Vomiting

Study type

Observational

Funder types

Other

Identifiers

NCT07244575
E2025278

Details and patient eligibility

About

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.

Full description

This is a prospective observational cohort study involving patients undergoing surgery under general anesthesia with endotracheal intubation at the Sixth Affiliated Hospital of Sun Yat-sen University. A total of 909 participants will be enrolled into either the metformin-exposed group (n=303) or the non-exposed group (n=606) . The primary outcome is the incidence of postoperative nausea and vomiting (PONV) within 0-120 hours after surgery. Secondary outcomes comprise the incidence and severity of PONV during different intervals, use of antiemetics, and quality of recovery (assessed by the QoR-15 score).

Enrollment

909 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

Exclusion criteria

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

Trial design

909 participants in 2 patient groups

Exposure group
Description:
Patients are already prescribed metformin before surgery
The non-exposure group
Description:
Patients are not prescribed metformin before surgery

Trial contacts and locations

1

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Central trial contact

Yang Zhao, Doctor

Data sourced from clinicaltrials.gov

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