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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: Angel-6000D Multiparameter Anesthesia Monitor (IoC)
* Device: BIS VISTA Monitor (BIS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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)<br>* The Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China<br>* Other names: Index of consciousness;|
| Placebo Comparator: control group<br>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)<br>* BIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China<br>* Other names: Bispectral index;|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IoC, monitor, elderly, postoperative effectiveness