Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
NCT Number: NCT01809041
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.
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Notify Me60 year–100 year
All sexes
Interventional
Phase 4
Guangzhou, Guangdong, 510120, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At 7 days after the surgery
Incidence of POCD in patients will be determined by a set of cognitive tests.
Time frame: At 3 months after the surgery
Incidence of POCD in patients will be determined by a set of cognitive tests.
Time frame: up to 2 weeks after the surgery
when bowel movement is returned.
Time frame: Up to 1 day after the surgery
blood concentrations of stress hormones.
Time frame: Up to 3 months after the surgery
duration of staying in the hospital
Time frame: Up to one year after the surgery
Migration, invasion and metastasis of the cancer
Time frame: Up to 7 days after surgery
inflammatory cytokines in the blood
Time frame: Up to 7 days after surgery
such as length of the telomere
Sun Yat-sen University
Other
Comparison of Total Intravenous Anesthesia With Sevoflurane-based Balanced Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients for Major Elective Intra-abdominal Surgery
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