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Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction

Primary Purpose

Intra-abdominal and Intrapelvic Surgery

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Sevoflurane

propofol

remifentanil

About this trial

This is an interventional prevention trial for Intra-abdominal and Intrapelvic Surgery

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

major elective gastrointestinal, gynecological, prostate or bladder surgery patients who are ≥ 60 years old.
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.
lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed.

Exclusion Criteria:

Patients are not expected to be alive for longer than 3 months.
Mini-mental State Examination (MMSE) [18] score ≤ 23.
history of dementia, psychiatric illness or any diseases of central nervous system.
current use of sedatives or antidepressant.
alcoholism and drug dependence.
patients previously included in this study (for patients who have second intra-abdominal surgery during the study period).
difficult to follow up or patients with poor compliance.
uncontrolled hypertension (> 180/100 mmHg)

Sites / Locations

Sun Yat-Sen Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sevoflurane & remifentanil

propofol & remifentanil

Arm Description

sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.

propofol (50 - 150 µg/kg/min) and remifentanil (0.1 - 0.5 µg/kg/min)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01809041

First Posted

March 6, 2013

Last Updated

June 19, 2023

Sponsor

Sun Yat-sen University

Collaborators

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.

1. Study Identification

Unique Protocol Identification Number

NCT01809041

Brief Title

Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction

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 Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

April 2019 (Actual)

Study Completion Date

April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intra-abdominal and Intrapelvic Surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

684 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sevoflurane & remifentanil

Arm Type

Experimental

Arm Description

sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.

Arm Title

propofol & remifentanil

Arm Type

Active Comparator

Arm Description

propofol (50 - 150 µg/kg/min) and remifentanil (0.1 - 0.5 µg/kg/min)

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Intervention Type

Drug

Intervention Name(s)

propofol

Intervention Type

Drug

Intervention Name(s)

remifentanil

Primary Outcome Measure Information:

Title

Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)

Description

Incidence of POCD in patients will be determined by a set of cognitive tests.

Time Frame

At 7 days after the surgery

Secondary Outcome Measure Information:

Title

Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)

Description

Incidence of POCD in patients will be determined by a set of cognitive tests.

Time Frame

At 3 months after the surgery

Other Pre-specified Outcome Measures:

Title

Time for bowel function return after surgery

Description

when bowel movement is returned.

Time Frame

up to 2 weeks after the surgery

Title

Degree of increase of stress hormones

Description

blood concentrations of stress hormones.

Time Frame

Up to 1 day after the surgery

Title

Length of hospital stay

Description

duration of staying in the hospital

Time Frame

Up to 3 months after the surgery

Title

colorectal cancer progress

Description

Migration, invasion and metastasis of the cancer

Time Frame

Up to one year after the surgery

Title

degree of systemic inflammation

Description

inflammatory cytokines in the blood

Time Frame

Up to 7 days after surgery

Title

aging biochemical markers

Description

such as length of the telomere

Time Frame

Up to 7 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: major elective gastrointestinal, gynecological, prostate or bladder surgery patients who are ≥ 60 years old. 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. lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed. Exclusion Criteria: Patients are not expected to be alive for longer than 3 months. Mini-mental State Examination (MMSE) [18] score ≤ 23. history of dementia, psychiatric illness or any diseases of central nervous system. current use of sedatives or antidepressant. alcoholism and drug dependence. patients previously included in this study (for patients who have second intra-abdominal surgery during the study period). difficult to follow up or patients with poor compliance. uncontrolled hypertension (> 180/100 mmHg)

Facility Information:

Facility Name

Sun Yat-Sen Memorial Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

18156878

Citation

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.

Results Reference

background

PubMed Identifier

11172175

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.

Results Reference

background

PubMed Identifier

19225398

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.

Results Reference

background

PubMed Identifier

12648190

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.

Results Reference

background

PubMed Identifier

7791257

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.

Results Reference

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Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction

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