Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction

NCT01809041 | Completed Phase 4

• 1 other identifier: ZZuo-POCD-1
• Study Type: interventional
• Target: 684
• Locations: 1 country
• Sites: 1

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.

Conditions

Intra-abdominal and Intrapelvic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  At 3 months after the surgery

Other Outcomes (6)

• Time for bowel function return after surgery

  up to 2 weeks after the surgery

• Degree of increase of stress hormones

  Up to 1 day after the surgery

• Length of hospital stay

  Up to 3 months after the surgery

Study Arms (2)

Sevoflurane & remifentanil

EXPERIMENTAL

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

propofol & remifentanil

ACTIVE COMPARATOR

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

Drug: propofol; Drug: remifentanil

Interventions

Sevoflurane DRUG

Sevoflurane & remifentanil

propofol DRUG

propofol & remifentanil

remifentanil DRUG

Sevoflurane & remifentanil; propofol & remifentanil

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Huaqiao Hospital in Guangzhou, China: collaborator
• First People's Hospital of Foshan: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Guangdong Provincial People's Hospital, China: collaborator
• Baxter (China) Investment Co. Ltd.: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

Related Publications (5)

• 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.

  PMID: 18156878 BACKGROUND

• 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.

  PMID: 11172175 BACKGROUND

• 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.

  PMID: 19225398 BACKGROUND

• 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.

  PMID: 12648190 BACKGROUND

• 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.

  PMID: 7791257 BACKGROUND

MeSH Terms

Interventions

Sevoflurane; Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 12, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)