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Postoperative Nausea and VomitingMet-PONVNCT07244575

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

An observational study of Postoperative Nausea and Vomiting, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Nausea and Vomiting
How many people
909 participants
Where
1 siteChina
Study dates
1 Dec 2025to 31 Dec 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients scheduled for surgery under general anesthesia with tracheal intubation

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • Presence of nausea and/or vomiting prior to surgery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Yang Zhao, Doctor, 0086-13802435520, zhaoy47@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Association Between Preoperative Metformin Exposure and Postoperative Nausea and Vomiting in Patients Undergoing General Anesthesia: a Prospective Observational Cohort Study

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.

Read the 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).

Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07244575
Study groupRoleWhat they receive
Exposure groupPatients are already prescribed metformin before surgery
The non-exposure groupPatients are not prescribed metformin before surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During 0-120 hour after surgery

Secondary outcomes (9)
  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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: During 0-24 hour after surgery

  5. 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.

    Measured: During 24-120 hour after surgery

  6. Use of antiemetics during 0-24 hours after surgery

    Use of antiemetics after surgery

    Measured: During 0-24 hours after surgery

  7. Use of antiemetics during 24-120 hours after surgery

    Use of antiemetics after surgery

    Measured: During 24-120 hours after surgery

  8. Use of antiemetics during 0-120 hours after surgery

    Use of antiemetics after surgery

    Measured: During 0-120 hours after surgery

  9. 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.

    Measured: Evaluated before surgery, at 24-hour, 48-hour, 72-hour, 96-hour, 120-hour after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
909 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07244575
Sponsor's protocol ID
E2025278
Acronym
Met-PONV
Status last verified
Feb 2026
First submitted
17 Nov 2025
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: only IPD used in the results publication

Publications

  • Kincaid JWR, Rimmington D, Tadross JA, Cimino I, Zvetkova I, Kaser A, Richards P, Patel S, O'Rahilly S, Coll AP. The gastrointestinal tract is a major source of the acute metformin-stimulated rise in GDF15. Sci Rep. 2024 Jan 22;14(1):1899. doi: 10.1038/s41598-024-51866-2.

    PubMed 38253650
  • Bootcov MR, Bauskin AR, Valenzuela SM, Moore AG, Bansal M, He XY, Zhang HP, Donnellan M, Mahler S, Pryor K, Walsh BJ, Nicholson RC, Fairlie WD, Por SB, Robbins JM, Breit SN. MIC-1, a novel macrophage inhibitory cytokine, is a divergent member of the TGF-beta superfamily. Proc Natl Acad Sci U S A. 1997 Oct 14;94(21):11514-9. doi: 10.1073/pnas.94.21.11514.

    PubMed 9326641
  • Al-Kuraishy HM, Al-Gareeb AI, Alexiou A, Papadakis M, Nadwa EH, Albogami SM, Alorabi M, Saad HM, Batiha GE. Metformin and growth differentiation factor 15 (GDF15) in type 2 diabetes mellitus: A hidden treasure. J Diabetes. 2022 Dec;14(12):806-814. doi: 10.1111/1753-0407.13334. Epub 2022 Nov 28.

    PubMed 36444166
  • Bu XS, Zhang J, Zuo YX. Validation of the Chinese Version of the Quality of Recovery-15 Score and Its Comparison with the Post-Operative Quality Recovery Scale. Patient. 2016 Jun;9(3):251-9. doi: 10.1007/s40271-015-0148-6.

    PubMed 26518201
  • Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.

    PubMed 22290456
  • Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

    PubMed 10485781
  • Sharma N, MacGibbon KW, Brecht-Doscher A, Cortessis VK, Fejzo MS. Prepregnancy metformin use associated with lower risk of severe nausea and vomiting of pregnancy and hyperemesis gravidarum. Am J Obstet Gynecol. 2025 Dec;233(6):649.e1-649.e14. doi: 10.1016/j.ajog.2025.06.055. Epub 2025 Jun 28.

    PubMed 40588059
  • Sillis L, Heinonen EW, Ceulemans M, Johnson D, Luo Y, Chambers CD. Metformin for the Prevention of Hyperemesis Gravidarum: An Observational Cohort Study. BJOG. 2025 Nov;132(12):1772-1778. doi: 10.1111/1471-0528.18238. Epub 2025 May 29.

    PubMed 40443168
  • Day EA, Ford RJ, Smith BK, Mohammadi-Shemirani P, Morrow MR, Gutgesell RM, Lu R, Raphenya AR, Kabiri M, McArthur AG, McInnes N, Hess S, Pare G, Gerstein HC, Steinberg GR. Metformin-induced increases in GDF15 are important for suppressing appetite and promoting weight loss. Nat Metab. 2019 Dec;1(12):1202-1208. doi: 10.1038/s42255-019-0146-4. Epub 2019 Dec 9.

    PubMed 32694673
  • Mai Y, Zhang S, Huang Q, Liang C, Shi J, Zheng J, Lv K, Liu H, Yang X, Zhao Y. Association between plasma growth differentiation factor-15 and postoperative nausea and vomiting incidence and severity: a secondary analysis of a randomised trial. Br J Anaesth. 2025 Aug;135(2):459-468. doi: 10.1016/j.bja.2025.05.001. Epub 2025 May 29.

    PubMed 40441987
  • Hsu JY, Crawley S, Chen M, Ayupova DA, Lindhout DA, Higbee J, Kutach A, Joo W, Gao Z, Fu D, To C, Mondal K, Li B, Kekatpure A, Wang M, Laird T, Horner G, Chan J, McEntee M, Lopez M, Lakshminarasimhan D, White A, Wang SP, Yao J, Yie J, Matern H, Solloway M, Haldankar R, Parsons T, Tang J, Shen WD, Alice Chen Y, Tian H, Allan BB. Non-homeostatic body weight regulation through a brainstem-restricted receptor for GDF15. Nature. 2017 Oct 12;550(7675):255-259. doi: 10.1038/nature24042. Epub 2017 Sep 27.

    PubMed 28953886
  • Cheng W, Gordian D, Ludwig MQ, Pers TH, Seeley RJ, Myers MG Jr. Hindbrain circuits in the control of eating behaviour and energy balance. Nat Metab. 2022 Jul;4(7):826-835. doi: 10.1038/s42255-022-00606-9. Epub 2022 Jul 25.

    PubMed 35879458
  • Borner T, Tinsley IC, Milliken BT, Doebley SA, Najjar NR, Kerwood DJ, De Jonghe BC, Hayes MR, Doyle RP. Creation of a Peptide Antagonist of the GFRAL-RET Receptor Complex for the Treatment of GDF15-Induced Malaise. J Med Chem. 2023 Aug 24;66(16):11237-11249. doi: 10.1021/acs.jmedchem.3c00667. Epub 2023 Jul 28.

    PubMed 37506293
  • Liu ZY, Yang XY, Lv C, Ye L, Chen JJ, Chen XY, Wang SP, Wu L, Zhang WQ, Lu M, Guo XW. Effect of High Maintenance Dose Versus Low Dose of Remifentanil on Incidence of Postoperative Nausea and Vomiting (PONV) in Patients Under Gynecological Laparoscopic Procedure: A Pilot Study. Drug Des Devel Ther. 2025 Jun 7;19:4885-4894. doi: 10.2147/DDDT.S518291. eCollection 2025.

    PubMed 40502550
  • Zhang Q, Ye X, Shi S, Zhou S, Ma D, Ouyang W, Tong J, Le Y. Pyridoxine Prevents Postoperative Nausea and Vomiting in Gynecologic Laparoscopic Surgery: A Double-blind Randomized Controlled Trial. Anesthesiology. 2025 Apr 1;142(4):655-665. doi: 10.1097/ALN.0000000000005354. Epub 2024 Dec 27.

    PubMed 39729294

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Nausea and Vomiting, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yang Zhao, Doctor (0086-02038254070, zhaoy47@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of PONV during 0-120 postoperative hours (time frame: During 0-120 hour after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07244575, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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