Skip to main content
OpenTrials
Completed

NCT Number: NCT01809041

Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sevoflurane

Drug

Propofol

Drug

Remifentanil

Drug

Primary outcomes

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

    Time frame: At 7 days after the surgery

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

Secondary outcomes

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

    Time frame: At 3 months after the surgery

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

Other outcomes

  1. Time for bowel function return after surgery

    Time frame: up to 2 weeks after the surgery

    when bowel movement is returned.

  2. Degree of increase of stress hormones

    Time frame: Up to 1 day after the surgery

    blood concentrations of stress hormones.

  3. Length of hospital stay

    Time frame: Up to 3 months after the surgery

    duration of staying in the hospital

  4. colorectal cancer progress

    Time frame: Up to one year after the surgery

    Migration, invasion and metastasis of the cancer

  5. degree of systemic inflammation

    Time frame: Up to 7 days after surgery

    inflammatory cytokines in the blood

  6. aging biochemical markers

    Time frame: Up to 7 days after surgery

    such as length of the telomere

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study title

Comparison of Total Intravenous Anesthesia With Sevoflurane-based Balanced Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients for Major Elective Intra-abdominal Surgery

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2013
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.