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

NCT ID: NCT07244575

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

909 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2033-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposure group

Patients are already prescribed metformin before surgery

No interventions assigned to this group

The non-exposure group

Patients are not prescribed metformin before surgery

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yang Zhao

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Zhao, Dr

Role: PRINCIPAL_INVESTIGATOR

The Sixth Affiliated Hospital, Sun Yat-sen University

Locations

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The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Yang Zhao, Doctor

Role: CONTACT

0086-02038254070

Facility Contacts

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Yang Zhao, Doctor

Role: primary

0086-13802435520

References

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Other Identifiers

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E2025278

Identifier Type: -

Identifier Source: org_study_id

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