The gastrointestinal tract is a major source of the acute metformin-stimulated rise in GDF15.
John W R Kincaid, Debra Rimmington, John A Tadross...
https://pubmed.ncbi.nlm.nih.gov/38253650Actively Recruiting
Age: 18Years +
All Genders
ID07244575
Association Between Preoperative Metformin Exposure and Postoperative Nausea and Vomiting in Patients Undergoing General Anesthesia: a Prospective Observational Cohort Study
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-02-09
909
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether taking metformin before surgery affects the chances or severity of nausea and vomiting after surgery in patients who undergo general anesthesia with endotracheal intubation. This observational cohort study compares patients already prescribed metformin with those not taking the medication, aiming to understand its influence on postoperative nausea and vomiting (PONV) and recovery quality. The study is conducted at the Sixth Affiliated Hospital of Sun Yat-sen University and enrolls a total of 909 participants. Participants are divided into two groups: those exposed to metformin before surgery and those not exposed. The primary focus is on the occurrence of PONV within 0 to 120 hours after surgery. Secondary aspects include measuring PONV incidence and severity at different time intervals, antiemetic medication use, and quality of recovery using the QoR-15 score assessed before surgery and at multiple points up to 120 hours post-surgery. During the study, patients will complete structured surveys assessing nausea and vomiting after their surgery. Researchers will collect data on recovery quality and medication use. The main outcome measured is the incidence of PONV during the first five days after surgery. The study began in December 2025 and will continue until December 2033, with participants monitored closely during the postoperative period for a detailed understanding of recovery outcomes and side effects.
CONDITIONS
Brief Title
Association Between Preoperative Metformin Exposure and Postoperative Nausea and Vomiting in Patients Undergoing General Anesthesia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Age 18 years or older
- Scheduled for surgery under general anesthesia with endotracheal intubation as determined by the treating physician
You will not qualify if you...
- Emergency surgery
- Taking medications with antiemetic effects such as corticosteroids or antipsychotics
- Cognitive impairment or psychiatric disorders preventing cooperation with questionnaires
- Expected inability to remove the breathing tube after surgery
- Presence of nausea or vomiting before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 120 hours after surgery
Participants undergo surgery under general anesthesia with endotracheal intubation and are observed immediately after surgery.
Assessments during hospital stay including up to 5 evaluations of recovery quality and monitoring of nausea and vomiting
Post-operative Follow-up
Duration - 0 to 120 hours after surgery
Participants are monitored for the incidence and severity of postoperative nausea and vomiting, use of antiemetics, and quality of recovery for up to 5 days after surgery.
Multiple assessments at 24, 48, 72, 96, and 120 hours after surgery
Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
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Research Team
Y
Yang Zhao, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Hayder M Al-Kuraishy, Ali I Al-Gareeb, Athanasios Alexiou...
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Neelu Sharma, Kimber W MacGibbon, Aimee Brecht-Doscher...
https://pubmed.ncbi.nlm.nih.gov/40588059Metformin for the Prevention of Hyperemesis Gravidarum: An Observational Cohort Study.
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Emily A Day, Rebecca J Ford, Brennan K Smith...
https://pubmed.ncbi.nlm.nih.gov/32694673Association between plasma growth differentiation factor-15 and postoperative nausea and vomiting incidence and severity: a secondary analysis of a randomised trial.
Yichi Mai, Shimin Zhang, Qingshan Huang...
https://pubmed.ncbi.nlm.nih.gov/40441987