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

Официальное название

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

Обзор

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.

Подробное описание

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).

Первичные конечные точки

• The incidence of PONV during 0-120 postoperative hours [Срок оценки: During 0-120 hour after surgery]

Вторичные конечные точки (9)

• The incidence PONV during 0-24 hour after surgery [Срок оценки: During 0-24 hour after surgery]
• The incidence PONV during 24-120 hour after surgery [Срок оценки: During 24-120 hour after surgery]
• The total severity of PONV during 0-120 hour after surgery [Срок оценки: During 0-120 hour after surgery]
• The severity of PONV during 0-24 hour after surgery [Срок оценки: During 0-24 hour after surgery]
• The severity of PONV during 24-120 hour after surgery [Срок оценки: During 24-120 hour after surgery]
• Use of antiemetics during 0-24 hours after surgery [Срок оценки: During 0-24 hours after surgery]
• Use of antiemetics during 24-120 hours after surgery [Срок оценки: During 24-120 hours after surgery]
• Use of antiemetics during 0-120 hours after surgery [Срок оценки: During 0-120 hours after surgery]
• Quality of Recovery (QoR-15 score) from 0 to 120 hour after surgery [Срок оценки: Evaluated before surgery, at 24-hour, 48-hour, 72-hour, 96-hour, 120-hour after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 40443168

Идентификаторы

NCT: NCT07244575 · E2025278

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗