Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01809041
• Collaborator: First Affiliated Hospital, Sun Yat-Sen University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), Huaqiao Hospital in Guangzhou, China (Other), First People's Hospital of Foshan (Other), Nanfang Hospital of Southern Medical University (Other), Guangdong Provincial People's Hospital, China (Other), Baxter (China) Investment Co. Ltd. (Industry)
• Enrollment: 684
• Location: 1
• Arms: 2
• Duration (Months): 73
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intra-abdominal and Intrapelvic Surgery	Drug: Sevoflurane; Drug: propofol; Drug: remifentanil	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 684 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevoflurane & remifentanil sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.	Drug: Sevoflurane; Drug: remifentanil
Active Comparator: propofol & remifentanil propofol (50 - 150 µg/kg/min) and remifentanil (0.1 - 0.5 µg/kg/min)	Drug: propofol; Drug: remifentanil

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. Time for bowel function return after surgery [up to 2 weeks after the surgery]

   when bowel movement is returned.

2. Degree of increase of stress hormones [Up to 1 day after the surgery]

   blood concentrations of stress hormones.

3. Length of hospital stay [Up to 3 months after the surgery]

   duration of staying in the hospital

4. colorectal cancer progress [Up to one year after the surgery]

   Migration, invasion and metastasis of the cancer

5. degree of systemic inflammation [Up to 7 days after surgery]

   inflammatory cytokines in the blood

6. aging biochemical markers [Up to 7 days after surgery]

   such as length of the telomere

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

• Sun Yat-sen University
• 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 of Southern Medical University
• Guangdong Provincial People's Hospital, China
• Baxter (China) Investment Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Erratum in: N Engl J Med 2001 Jun 14;344(24):1876.
• 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.
• 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.
• 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.

• Responsible Party: Zhiyi Zuo, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01809041
• Other Study ID Numbers: ZZuo-POCD-1
• First Posted: Mar 12, 2013
• Last Update Posted: Jul 16, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction; Remifentanil; Propofol; Sevoflurane

Study Results

No Results Posted as of Jul 16, 2020