Intra-abdominal and Intrapelvic Surgery
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGSevoflurane
DRUGpropofol
DRUGremifentanil
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Huaqiao Hospital in Guangzhou, China
First People's Hospital of Foshan
Nanfang Hospital, Southern Medical University
Guangdong Provincial People's Hospital, China
Baxter (China) Investment Co. Ltd.
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) | At 7 days after the surgery | Incidence of POCD in patients will be determined by a set of cognitive tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) | At 3 months after the surgery | Incidence of POCD in patients will be determined by a set of cognitive tests. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Up to 3 months after the surgery | duration of staying in the hospital |
| colorectal cancer progress | Up to one year after the surgery | Migration, invasion and metastasis of the cancer |
| Time for bowel function return after surgery | up to 2 weeks after the surgery | when bowel movement is returned. |
| aging biochemical markers | Up to 7 days after surgery | such as length of the telomere |
| degree of systemic inflammation | Up to 7 days after surgery | inflammatory cytokines in the blood |
| Degree of increase of stress hormones | Up to 1 day after the surgery | blood concentrations of stress hormones. |
Countries
China
Outcome results
None listed