Effect of Depth of Total Intravenous Anesthesia Using Propofol on Postoperative Cognitive Dysfunction

May 29, 2013 updated by: Xiangya Hospital of Central South University

Effect of Depth of Total Intravenous Anesthesia Using Propofol on Postoperative Cognitive Dysfunction : A Multi-Center Study

The purpose of this study is to investigate whether the depth of anesthesia with propofol affects the incidence of early postoperative cognitive dysfunction

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION

1.1 Rationale for the study

There is a significant relation between postoperative cognitive dysfunction and increasing age, increasing duration of surgery. But, up to now, the effect of the depth of anesthesia on POCD remains controversial. This study is designed to investigate whether the depth of anesthesia affects the incidence of POCD, we will use propofol for total intravenous anesthesia in elderly patients whose depth of anesthesia was monitored and adjusted by bispectral index (BIS). The early and long-term incidence of POCD will be compared between deep and light-anesthesia groups.

1.2 Background

We hypothesize that depth of anesthesia may exert an influence on the early postoperative cognitive dysfunction. One reason that deep anesthesia might protect cognitive function is the prevention of the stress response to noxious stimulation. The noxious stimulation of surgery can induce stress responses whose severity correlates with the intensity of surgery (major versus minor).Light anesthesia with a serious stress response to noxious stimulation may increase the incidence of POCD. Furthermore, major surgery causing a serious stress response can give rise to a higher incidence of early postoperative cognitive dysfunction than minor. This may also prove our hypothesis on the other hand. The elderly patients who received major surgery had a higher incidence of early POCD than those who received minor surgery. A deleterious stress response can be associated with major surgery or light anesthesia, and it can cause excessive production of corticosteroids that target receptors in the cerebral cortex and subcortical nucleus, eventually resulting in neuron injury. This may explain why the elderly has a higher incidence of early POCD after surgery. However, the effect of the depth of anesthesia on POCD remains controversial. Farag E et al. randomized 74 patients to either a low Bispectral Index (BIS) regimen or a high BIS regimen during the surgical procedure. Preoperatively and 4-6 week after surgery, the patients' cognitive status was assessed with a cognitive test battery consisting of processing speed index, working memory index, and verbal memory index. Processing speed index was higher in the low BIS group versus the high BIS group. But no difference was observed in the other two test battery components. Certainly one of the limitations of their data is that the observed difference in cognitive ability occurred in only one of three assessments. Recently, we have made a randomised, double-blind, controlled study to demonstrate that deeper general anesthesia, as defined by a median BIS of 38, when compared with a median BIS of 58, was associated with a reduced incidence of early POCD(at 1 week postoperationly). This study has been published in J Neurosurg Anesthesiol , Volume 23, Number 1, January 2011. as it was just a small sample(n=40) study without considering incidence of long-term POCD, we hope to obtain more reliable data from a multi-center study to investigate whether the depth of total intravenous anesthesia using propofol affects the early and long-term incidence of POCD.

The bispectral index（BIS）can reflect the depth of anesthesia of propofol combined with opioids. In our study, BIS will still be used to provide a reference for the selection of a suitable depth of anesthesia.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410078
        • Xiangya Hospital, Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent provided by legal guardians or patients
  • Male or female patients between 50 and 70 years of age.
  • ASA physical status I or II patients.
  • Education Years of patients are more than 6 years.
  • The operation going to be received is the first operation in patient's life (a second operation was a risk factor for early post- operative cognitive dysfunction);
  • The operation going to be received is presenting for a moderate surgery, such as pulmonary lobectomy, subtotal gastrectomy, prostatectomy and so on.

Exclusion Criteria:

  • The patient has the history of neurologic or mental disease.
  • The patient has renal dysfunction, serum creatinine >177 mmol/L.
  • The patient has an active liver disease.
  • The patient has cardiac dysfunction.
  • The patient has pulmonary dysfunction.
  • The patient has an endocrine disease.
  • The patient has a metabolic disease.
  • The patient has a history of surgery.
  • The patient is going to receive surgery of thyroid, intracranial procedure, joint replacement, major fracture.
  • The patient's education history is shown less than 6 years of school.
  • The patient is unable to complete neuropsychologic testing.
  • The patient has vision dysfunction.
  • The patient has auditory dysfunction.
  • The operation going to be received is a laparoscopic surgery.
  • The patient is hypersensitive to propofol or any other anesthetic agents.
  • Involvement in the planning and conduct of the study
  • Participation in another drug trial within 28 days prior enrolment into this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: deep anesthesia group
Propofol infusion rate is titrated to maintain the target BIS values in 30-45
Drug: Propofol
Propofol infusion rate is titrated to maintain the target BIS values
Other: light anesthesia group
Propofol infusion rate is titrated to maintain the target BIS values in 45-60
Drug: Propofol
Propofol infusion rate is titrated to maintain the target BIS values

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function score measured by Wechsler memory scale/ Wechsler intelligence scale manual
Time Frame: Three month
cognitive function test using Wechsler memory scale/ Wechsler intelligence scale manual were administered the day before and 7 days and 3 months after surgery.
Three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Investigators

  • Study Director: Qulian Guo, PhD, Xiangya Hospital, Central South University, Changsha, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

October 7, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSDIPR0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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