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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05173909
Enrollment
73
Registered
2021-12-30
Start date
2018-01-01
Completion date
2020-12-01
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEBIS 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

Sponsors

Zhonghua Chen,MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes 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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative complicationsWithin one week after surgerypulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
mortality rateWithin 30 days after surgerymortality rate
Serum LEVELS of IL-2, IL-4, IL-6, IL-10, TNF-ɑ, IFN-γWithin three days of the surgerySerum 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026