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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Huaqiao Hospital in Guangzhou, China | OTHER |
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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.
Patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly assigned into two groups: 1) sevoflurane-based general anesthesia group, and 2) propofol-based general anesthesia group. Each group will need 221 patients to detect 1/3 of decrease or increase in the rate of POCD of one group compared with another group at about one week after surgery, assuming the overall rate of POCD at this time is about 40% at this time. Considering about 10% loss to follow-up, we will have 250 patients in each group. In addition, investigators will need 184 subjects in the control group. The data of these control subjects will be used to normalize the data of the two studied groups to diagnose POCD. The subjects in control groups will also be elderly but without the exposure to anesthesia and surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane & remifentanil | Experimental | sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery. |
|
| propofol & remifentanil | Active Comparator | propofol (50 - 150 µg/kg/min) and remifentanil (0.1 - 0.5 µg/kg/min) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug |
| ||
| propofol |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) | Incidence of POCD in patients will be determined by a set of cognitive tests. | At 7 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) | Incidence of POCD in patients will be determined by a set of cognitive tests. | At 3 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time for bowel function return after surgery | when bowel movement is returned. | up to 2 weeks after the surgery |
| Degree of increase of stress hormones | blood concentrations of stress hormones. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18156878 | 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. | |
| 11172175 | 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. |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| First People's Hospital of Foshan |
| OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Guangdong Provincial People's Hospital, China | UNKNOWN |
| Baxter (China) Investment Co. Ltd. | INDUSTRY |
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|
| remifentanil | Drug |
|
| Up to 1 day after the surgery |
| Length of hospital stay | duration of staying in the hospital | Up to 3 months after the surgery |
| colorectal cancer progress | Migration, invasion and metastasis of the cancer | Up to one year after the surgery |
| degree of systemic inflammation | inflammatory cytokines in the blood | Up to 7 days after surgery |
| aging biochemical markers | such as length of the telomere | Up to 7 days after surgery |
| 19225398 | 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. |
| 12648190 | 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. |
| 7791257 | 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. |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |