Effects of BIS Closed Loop Target Controlled Infusion on Perioperative Inflammatory Response and Prognosis of Elderly Patients Undergoing Laparoscopic Radical Gastrectomy for Gastric Cancer

The purpose of this study is to find the elderly patients with laparoscopic gastric cancer radical is suitable the BIS closed round target control level of anesthesia depth of sedation, can decrease the elderly laparoscopic gastric cancer radical surgery in patients with perioperative inflammatory reaction, and reduce the incidence of perioperative pulmonary complications such as, for elderly patients with gastric cancer radical perioperative inflammation control to provide the reference and provide guidance for clinical anesthesia work.

Study Overview

• Status: Completed
• Conditions: The Effect of BIS Closed-loop Target Control on Postoperative Operation
• Intervention / Treatment: Device: BIS closed-loop target controlled infusion

Detailed Description

In this study, elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer were randomly divided into BIS closed circle target controlled infusion (BIS) 55 group and 45 group, and the levels of perioperative inflammatory response indicators IL-6, TNF-α and IL-10 at different depths of anesthesia and sedation were recorded. The duration of stay in anesthesia recovery room, quality of recovery, postoperative pain and postoperative pulmonary complications were observed. Objective To evaluate the feasibility of BIS closed loop target controlled infusion in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer.

Perioperative period is a process of intense stress response, which is mainly manifested by the production and aggregation of inflammatory factors, which adversely affect multiple organs such as brain, heart and lung, and is an important risk factor for increasing postoperative complications and postoperative mortality .

Perioperative inflammatory response status has a clear relationship with postoperative recovery of patients, and perioperative anesthesia and sedation depth management and precision anesthesia is one of the most critical links to control the stress response, and appropriate anesthesia and sedation depth control and stress regulation can significantly improve the prognosis of patients . How to reduce the adverse effects of perioperative stress response on patients has been the focus of research and attention in recent years.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaoxing, China
    • Shaoxing People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Age 65 or above ASA-PSTYPE I or II Both male and female Laparoscopic radical gastrectomy for gastric cancer

Exclusion Criteria:

The patient had abnormal liver, kidney and other important organs before surgery The patient has chronic pain Patients with neurological or mental disorders Long-term use of sedation, painkillers and antipsychotic drugs The patient has contraindications for opioid use

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group H; BIS closed-loop target controlled infusion group with BIS value of 55	Device: BIS closed-loop target controlled infusion; BIS was monitored by connecting the BIS monitor (BISXP, Aspects Medical Systems, USA). The corresponding value was set on the BIS detector and connected to the targy-controlled infusion pump to automatically adjust the plasma drug concentration of propofol
Experimental: group L; BIS closed-loop target controlled infusion group with BIS value of 45	Device: BIS closed-loop target controlled infusion; BIS was monitored by connecting the BIS monitor (BISXP, Aspects Medical Systems, USA). The corresponding value was set on the BIS detector and connected to the targy-controlled infusion pump to automatically adjust the plasma drug concentration of propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.	Within one week after surgery
mortality rate	mortality rate	Within 30 days after surgery
Serum LEVELS of IL-2, IL-4, IL-6, IL-10, TNF-ɑ, IFN-γ	Serum levels of IL-2, IL-4, IL-6, IL-10, TNF-ɑ and IFN-γ were determined immediately before operation, 2 hours after operation, 24 hours after operation and 72 hours after operation	Within three days of the surgery

Collaborators and Investigators

• Sponsor: Zhonghua Chen,MD

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: elderly patients; BIS closed-loop target controlled infusion; sedation deep; laparoscopic radical gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 032

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No