Intra-abdominal and Intrapelvic Surgery Clinical Trial
Official title:
Comparison of Total Intravenous Anesthesia With Sevoflurane-based Balanced Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients for Major Elective Intra-abdominal Surgery
| NCT number | NCT01809041 |
| Other study ID # | ZZuo-POCD-1 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | March 2013 |
| Est. completion date | April 2019 |
| Verified date | June 2023 |
| Source | Sun Yat-sen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 684 |
| Est. completion date | April 2019 |
| Est. primary completion date | April 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 60 Years to 100 Years |
| Eligibility | Inclusion Criteria: 1. major elective gastrointestinal, gynecological, prostate or bladder surgery patients who are = 60 years old. 2. the surgery is laparoscopic surgery and is expected to last for = 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery. 3. lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed. Exclusion Criteria: 1. Patients are not expected to be alive for longer than 3 months. 2. Mini-mental State Examination (MMSE) [18] score = 23. 3. history of dementia, psychiatric illness or any diseases of central nervous system. 4. current use of sedatives or antidepressant. 5. alcoholism and drug dependence. 6. patients previously included in this study (for patients who have second intra-abdominal surgery during the study period). 7. difficult to follow up or patients with poor compliance. 8. uncontrolled hypertension (> 180/100 mmHg) |
| Country | Name | City | State |
|---|---|---|---|
| China | Sun Yat-Sen Memorial Hospital | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Yat-sen University | Baxter (China) Investment Co. Ltd., First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Guangdong Provincial People's Hospital, China, Huaqiao Hospital in Guangzhou, China, Nanfang Hospital, Southern Medical University, Third Affiliated Hospital, Sun Yat-Sen University |
China,
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. — View Citation
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. Erratum In: N Engl J Med 2001 Jun 14;344(24):1876. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Time for bowel function return after surgery | when bowel movement is returned. | up to 2 weeks after the surgery | |
| Other | Degree of increase of stress hormones | blood concentrations of stress hormones. | Up to 1 day after the surgery | |
| Other | Length of hospital stay | duration of staying in the hospital | Up to 3 months after the surgery | |
| Other | colorectal cancer progress | Migration, invasion and metastasis of the cancer | Up to one year after the surgery | |
| Other | degree of systemic inflammation | inflammatory cytokines in the blood | Up to 7 days after surgery | |
| Other | aging biochemical markers | such as length of the telomere | Up to 7 days after surgery | |
| Primary | 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 | |
| Secondary | 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 |