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.
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).
Study Type
OBSERVATIONAL
Enrollment
909
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe 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
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
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
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
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
The severity of PONV during 24-120 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 25 to 120 hours postoperatively was calculated as the sum of the daily scores over this period.
Time frame: During 24-120 hour after surgery
Use of antiemetics during 0-24 hours after surgery
Use of antiemetics after surgery
Time frame: During 0-24 hours after surgery
Use of antiemetics during 24-120 hours after surgery
Use of antiemetics after surgery
Time frame: During 24-120 hours after surgery
Use of antiemetics during 0-120 hours after surgery
Use of antiemetics after surgery
Time frame: During 0-120 hours after surgery
Quality of Recovery (QoR-15 score) from 0 to 120 hour 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: Evaluated before surgery, at 24-hour, 48-hour, 72-hour, 96-hour, 120-hour after surgery
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