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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Angel-6000D Multiparameter Anesthesia Monitor (IoC)
BIS VISTA Monitor (BIS)
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring IoC, monitor, elderly, postoperative effectiveness

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • FirstXianJiaotongURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Duration time in PACU
patients able to leave PACU with the proper Aldrete score

Secondary Outcome Measures

Use of remifentanil
Use of propofol
length of hospital stay (LOS)

Full Information

First Posted
June 26, 2016
Last Updated
January 18, 2017
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT02827682
Brief Title
The Effect of IoC on Analgesia for Elderly Patients With Postoperative Effectiveness
Official Title
The Effect of IoC on the Level of Intraoperative Analgesia for Elderly Patients With Postoperative Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
IoC, monitor, elderly, postoperative effectiveness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Angel-6000D Multiparameter Anesthesia Monitor (IoC)
Other Intervention Name(s)
Index of consciousness
Intervention Description
The Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China
Intervention Type
Device
Intervention Name(s)
BIS VISTA Monitor (BIS)
Other Intervention Name(s)
Bispectral index
Intervention Description
BIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China
Primary Outcome Measure Information:
Title
Duration time in PACU
Description
patients able to leave PACU with the proper Aldrete score
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Use of remifentanil
Time Frame
during surgery
Title
Use of propofol
Time Frame
during surgery
Title
length of hospital stay (LOS)
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Xu, MD
Phone
13772052823
Email
xuj0909@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Wang, PHD
Phone
13991236768
Email
dr.wangqiang@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Wang, PHD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
FirstXianJiaotongU
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
QIANG WANG, PHD
Phone
18049286968
Email
dr.wangqiang@139.com
First Name & Middle Initial & Last Name & Degree
JING XU, MD
Phone
13772052823
Email
xuj0909@163.com
First Name & Middle Initial & Last Name & Degree
RUI BO SUN, MD
First Name & Middle Initial & Last Name & Degree
BIN GUAN, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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