drugset / Trial / NCT01809041
Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction
Phase 4
Completed
684 enrolled
Sun Yat-sen University
Baxter (China) Investment Co. Ltd. · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabFirst People's Hospital of Foshan · collabGuangdong Provincial People's Hospital, China · collabHuaqiao Hospital in Guangzhou, China · collabNanfang Hospital, Southern Medical University · collabThird Affiliated Hospital, Sun Yat-Sen University · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon. Most patients will receive general anesthesia during surgery. Two groups of general anesthetics are used for this purpose. We hypothesize that the incidence of POCD is not different in patients received intravenous anesthetics only or sevoflurane (a volatile anesthetic-based general anesthesia) for their major intra-abdominal surgery.
Timeline
- Start
- 2013-03
- Primary completion
- 2019-04
- Completion
- 2019-04
Publications
- Background Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
- Background Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.
- Background Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.
- Background Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.
- Background Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Propofol | Small molecule | 50 ug/kg | — |
| Comparator | Propofol | Small molecule | 150 ug/kg | — |
| Subject | Sevoflurane | Other / unclassified | 0.5 unknown | — |
| Subject | Sevoflurane | Other / unclassified | 1.5 unknown | — |
| Background | Remifentanil | Small molecule | 0.1 ug/kg | — |
| Background | Remifentanil | Small molecule | 0.5 ug/kg | — |
Indications
No indication recorded.