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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients scheduled for surgery under general anesthesia with tracheal intubation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

909 Participants
are grouped into 2 trial groups
Group A: Exposure group
Group B: The non-exposure group

Trial outcomes

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

Time frame
During 0-120 hour after surgery

Secondary outcomes

1

The incidence PONV during 0-24 hour after surgery

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

Time frame
During 0-24 hour after surgery
2

The incidence PONV during 24-120 hour after surgery

Trained blinded investigators collected information about PONV recorded by either the participants and their family members or medical staff in the ward every 24 h during the first 120 h after surgery.

Time frame
During 24-120 hour after surgery
3

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

Assessment was performed using a simplified Postoperative Nausea and Vomiting (PONV) Impact Scale. Nausea severity was scored as follows: 0 (none), 1 (occasional), 2 (frequent), and 3 (continuous). Vomiting or retching was scored based on the number of episodes: 0, 1, 2, or 3 (or ≥3 episodes). The scores for nausea and vomiting/retching were summed to generate a total daily score for each 24-hour postoperative period. A total daily score of ≥5 was defined as clinically significant PONV. The overall PONV severity from 0 to 120 hours postoperatively was calculated as the sum of the daily scores over this period, providing a cumulative measure of symptom burden.

Time frame
During 0-120 hour after surgery
4

The severity of PONV during 0-24 hour after surgery

Assessment was performed using a simplified Postoperative Nausea and Vomiting (PONV) Impact Scale. Nausea severity was scored as follows: 0 (none), 1 (occasional), 2 (frequent), and 3 (continuous). Vomiting or retching was scored based on the number of episodes: 0, 1, 2, or 3 (or ≥3 episodes). The scores for nausea and vomiting/retching were summed to generate a total daily score for each 24-hour postoperative period. A total daily score of ≥5 was defined as clinically significant PONV.

Time frame
During 0-24 hour after surgery

Other outcomes

1

Quality of recovery at 30-day after surgery

The QoR-15 is a 15-item questionnaire instrument designed to evaluate the quality of postoperative recovery in patients. It comprises five sub-scales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items). Each item is scored from 0 to 10, resulting in a total score ranging from 0 to 150. A higher score indicates a better quality of recovery for the patient.

Time frame
At 30-day after surgery
2

Incidence and grade of major postoperative complications

Incidence and grade of major postoperative complications

Time frame
During 30 day after surgery
3

PONV-related factors in the blood or urine.

PONV-related factors in the blood or urine

Time frame
from preoperative to postoperative
4

Overall survival rates

The status of live or death, and the death time

Time frame
1-year, 3-year, 5-year after surgery

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