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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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.
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.
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.
Other outcomes
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.
Incidence and grade of major postoperative complications
Incidence and grade of major postoperative complications
PONV-related factors in the blood or urine.
PONV-related factors in the blood or urine
Overall survival rates
The status of live or death, and the death time
Sponsors and contacts
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