The Effect of IoC on Analgesia for Elderly Patients With Postoperative Effectiveness

NCT ID: NCT02827682

Last Updated: 2017-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-05-31

Brief Summary

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The morbidity of colorectal cancer and the surgery number among elderly is growing. The investigators need to provide more advanced and specific monitoring technology for these patients. Index of consciousness (IoC) monitor is now widely used among endoscopy, cholecystectomy and other common clinical applications. The investigators goal is to verify whether using IoC monitor could help to improve the postoperative recovery after colorectal surgery.

Detailed Description

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Participants will be randomly assigned, in a 1:1 ratio, to receive IoC monitoring or BIS monitoring during the operation as the criteria for adjustment of analgesics use. The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. The number of dialysis and patient's recovery after the transplantation will be recorded. The participation of each patient is scheduled till they discharge from hospital.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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study group

Using Angel-6000D Multiparameter Anesthesia Monitor to maintain the Hemodynamic stability during surgery. Keep IoC1 40 to 60 while IoC2 30-50.Target concentration of propofol was decreased by 0.5 μg/ml per adjustment when IoC1\<40, with a maintenance value between 40 and 60. The target concentration of remifentanil was increased by 1 ng/ml per adjustment when IoC2\>50 but was decreased by 1 ng/ml per adjustment when IoC2\<30, with the maintenance value between 30 and 50.

Group Type EXPERIMENTAL

Angel-6000D Multiparameter Anesthesia Monitor (IoC)

Intervention Type DEVICE

The Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China

control group

Using BIS VISTA Monitor to maintain the Hemodynamic stability during surgery. Keep BIS 40 to 60.The doses of propofol and remifentanil were adjusted by the anesthetists according to BIS. Target concentration of propofol was decreased by 0.5 μg/ml per adjustment when BIS\<40, with a maintenance value between 40 and 60. The target concentration of remifentanil was increased by 1 ng/ml per adjustment when BIS\>60 but was decreased by 1 ng/ml per adjustment when BIS\<40, with the maintenance value between 40 and 60.

Group Type PLACEBO_COMPARATOR

BIS VISTA Monitor (BIS)

Intervention Type DEVICE

BIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China

Interventions

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Angel-6000D Multiparameter Anesthesia Monitor (IoC)

The Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China

Intervention Type DEVICE

BIS VISTA Monitor (BIS)

BIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China

Intervention Type DEVICE

Other Intervention Names

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Index of consciousness Bispectral index

Eligibility Criteria

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Inclusion Criteria

* Patients aged over 60 years old that underwent Colorectal surgery in the First Affiliated Hospital of Xi'an Jiaotong University.

Exclusion Criteria

* Having severe comorbidity history,for example,severe cardiac dysfunction
* Having central nervous system disease, severe endocrine, and history of mental disorders
* Alcoholic and long-term use of sedatives and opioids history
* Drug allergy history.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qiang Wang, PHD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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FirstXianJiaotongU

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Xu, MD

Role: CONTACT

13772052823

Qiang Wang, PHD

Role: CONTACT

13991236768

Facility Contacts

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QIANG WANG, PHD

Role: primary

18049286968

JING XU, MD

Role: backup

13772052823

Other Identifiers

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XJTU1AF-CRS-2016-017

Identifier Type: -

Identifier Source: org_study_id

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