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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: Angel-6000D Multiparameter Anesthesia Monitor (IoC); Device: BIS VISTA Monitor (BIS)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Xu, MD; Phone Number: 13772052823; Email: xuj0909@163.com
• Study Contact Backup: Name: Qiang Wang, PHD; Phone Number: 13991236768; Email: dr.wangqiang@139.com

Study Locations

• China
  • Shaanxi
    • Xian, Shaanxi, China, 710061
      • Recruiting
      • FirstXianJiaotongU
      • Contact: Jing Xu, MD; Phone Number: 13772052823; Email: xuj0909@163.com
      • Contact: QIANG WANG, PHD; Phone Number: 18049286968; Email: dr.wangqiang@139.com
      • Sub-Investigator: RUI BO SUN, MD
      • Sub-Investigator: BIN GUAN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Angel-6000D Multiparameter Anesthesia Monitor (IoC); The Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China; Other Names: Index of consciousness
Placebo Comparator: 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.	Device: BIS VISTA Monitor (BIS); BIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China; Other Names: Bispectral index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration time in PACU	patients able to leave PACU with the proper Aldrete score	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Qiang Wang, PHD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: June 26, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: elderly; monitor; IoC; postoperative effectiveness
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: XJTU1AF-CRS-2016-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No