NCT02827682

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

June 26, 2016

Last Update Submit

January 18, 2017

Conditions

Colorectal Cancer

Keywords

IoCmonitorelderlypostoperative effectiveness

Outcome Measures

Primary Outcomes (1)

  • Duration time in PACU

    patients able to leave PACU with the proper Aldrete score

    24 hours

Secondary Outcomes (3)

  • Use of remifentanil

    during surgery

  • Use of propofol

    during surgery

  • length of hospital stay (LOS)

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

study group

EXPERIMENTAL

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.

Device: Angel-6000D Multiparameter Anesthesia Monitor (IoC)

control group

PLACEBO COMPARATOR

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.

Device: BIS VISTA Monitor (BIS)

Interventions

Angel-6000D Multiparameter Anesthesia Monitor (IoC)DEVICE

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

Also known as: Index of consciousness
study group
BIS VISTA Monitor (BIS)DEVICE

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

Also known as: Bispectral index
control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FirstXianJiaotongU

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Consciousness Monitors

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Qiang Wang, PHD

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY CHAIR

Central Study Contacts

Jing Xu, MD

CONTACT

13772052823xuj0909@163.com

Qiang Wang, PHD

CONTACT

13991236768dr.wangqiang@139.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)