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

NCT ID: NCT05173909

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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The Effect of BIS Closed-loop Target Control on Postoperative Operation

Keywords

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BIS closed-loop target controlled infusion sedation deep laparoscopic radical gastrectomy elderly patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 73 patients were selected and divided into two groups according to random number table method: BIS closed loop target controlled infusion group with BIS value of 55 (group H) and BIS closed loop-target controlled infusion group with BIS value of 45 (group L), The final grouping results were 36 cases in group H and 37 cases in group L. All enrolled patients signed informed consent forms.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
None of the participants，care providers and outcomes assessors knew the grouping, and only the experimenter had to adjust BIS. In this way, the description of the treatment effects and adverse reactions of the subjects, as well as the recording of the experimenter's various reactions, can be as objective as possible.

Study Groups

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group H

BIS closed-loop target controlled infusion group with BIS value of 55

Group Type EXPERIMENTAL

BIS closed-loop target controlled infusion

Intervention Type DEVICE

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

group L

BIS closed-loop target controlled infusion group with BIS value of 45

Group Type EXPERIMENTAL

BIS closed-loop target controlled infusion

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhonghua Chen,MD

OTHER

Sponsor Role lead

Responsible Party

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Zhonghua Chen,MD

Head of anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shaoxing People's Hospital

Shaoxing, , China

Site Status

Countries

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China

Other Identifiers

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032

Identifier Type: -

Identifier Source: org_study_id