Postoperative Nausea and Vomiting
Conditions
Brief summary
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
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).
Interventions
None listed
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of PONV during 0-120 postoperative hours | During 0-120 hour after surgery | PONV is defined as the occurrence of any of the following symptoms: nausea, retching, or vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence PONV during 0-24 hour after surgery | 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 | 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 | 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 | 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. |
| The severity of PONV during 24-120 hour after surgery | 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. |
| Use of antiemetics during 0-24 hours after surgery | During 0-24 hours after surgery | Use of antiemetics after surgery |
| Use of antiemetics during 24-120 hours after surgery | During 24-120 hours after surgery | Use of antiemetics after surgery |
| Use of antiemetics during 0-120 hours after surgery | During 0-120 hours after surgery | Use of antiemetics after surgery |
| Quality of Recovery (QoR-15 score) from 0 to 120 hour after surgery | Evaluated before surgery, at 24-hour, 48-hour, 72-hour, 96-hour, 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. |
Countries
China
Contacts
CONTACTYang Zhao, Doctor
PRINCIPAL_INVESTIGATORYang Zhao, Dr
The Sixth Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed