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Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT01809041
Recruitment Status : Recruiting
First Posted : March 12, 2013
Last Update Posted : January 3, 2019
Sponsor:
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 of Southern Medical University
Guangdong Provincial People's Hospital
Baxter (China) Investment Co. Ltd.
Information provided by (Responsible Party):
Zhiyi Zuo, Sun Yat-sen University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809041


Contacts
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Contact: Yujuan Li, MD, PhD. 15918734156 yujuan_04@hotmail.com
Contact: Shulin Peng, MD, PhD 13662313366 pslmzk@yahoo.com.cn

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yujuan Li, MD, Ph.D.    15918734156    Yujuan_04@hotmail.com   
Principal Investigator: Yujuan Li         
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
Baxter (China) Investment Co. Ltd.

Publications:
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Responsible Party: Zhiyi Zuo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01809041     History of Changes
Other Study ID Numbers: ZZuo-POCD-1
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Propofol
Sevoflurane
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation