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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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BIS closed-loop target controlled infusion
Sponsored by
Zhonghua Chen,MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for The Effect of BIS Closed-loop Target Control on Postoperative Operation focused on measuring BIS closed-loop target controlled infusion, sedation deep, laparoscopic radical gastrectomy, elderly patients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shaoxing People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group H

group L

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative complications
pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
mortality rate
mortality rate
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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2021
Last Updated
December 28, 2021
Sponsor
Zhonghua Chen,MD
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1. Study Identification

Unique Protocol Identification Number
NCT05173909
Brief Title
Effects of BIS Closed Loop Target Controlled Infusion on Perioperative Inflammatory Response and Prognosis of Elderly Patients Undergoing Laparoscopic Radical Gastrectomy for Gastric Cancer
Official Title
Effects of BIS Closed Loop Target Controlled Infusion on Perioperative Inflammatory Response and Prognosis of Elderly Patients Undergoing Laparoscopic Radical Gastrectomy for Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhonghua Chen,MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Effect of BIS Closed-loop Target Control on Postoperative Operation
Keywords
BIS closed-loop target controlled infusion, sedation deep, laparoscopic radical gastrectomy, elderly patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group H
Arm Type
Experimental
Arm Description
BIS closed-loop target controlled infusion group with BIS value of 55
Arm Title
group L
Arm Type
Experimental
Arm Description
BIS closed-loop target controlled infusion group with BIS value of 45
Intervention Type
Device
Intervention Name(s)
BIS closed-loop target controlled infusion
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative complications
Description
pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
Time Frame
Within one week after surgery
Title
mortality rate
Description
mortality rate
Time Frame
Within 30 days after surgery
Title
Serum LEVELS of IL-2, IL-4, IL-6, IL-10, TNF-ɑ, IFN-γ
Description
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
Time Frame
Within three days of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shaoxing People's Hospital
City
Shaoxing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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