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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02827682
• Other study ID #: XJTU1AF-CRS-2016-017
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2016
• Last updated: January 18, 2017
• Start date: July 2016
• Est. completion date: May 2018

Study information

• Verified date: January 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jing Xu, MD
• Phone: 13772052823
• Email: xuj0909[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• Angel-6000D Multiparameter Anesthesia Monitor (IoC)
The Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China
• BIS VISTA Monitor (BIS)
BIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China

Locations

Country	Name	City	State
China	FirstXianJiaotongU	Xian	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration time in PACU	patients able to leave PACU with the proper Aldrete score	24 hours
Secondary	Use of remifentanil		during surgery
Secondary	Use of propofol		during surgery
Secondary	length of hospital stay (LOS)		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks