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

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Device: BIS VISTA Monitor (BIS); Device: Angel-6000D Multiparameter Anesthesia Monitor (IoC)

• Registration Number: NCT02827682
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study First Submitted: 2016-06-26
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20
• Primary Completion: 2017-12
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	BIS VISTA Monitor (BIS)	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.
study group	Angel-6000D Multiparameter Anesthesia Monitor (IoC)	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.

Primary Outcome Measures

Name	Time	Method
Duration time in PACU	24 hours	patients able to leave PACU with the proper Aldrete score

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

FirstXianJiaotongU; 🇨🇳 Xian, Shaanxi, China