Effect and Mechanism of Remimazolam Benzenesulfonate on Enhanced Recovery After Surgery in Patients Undergoing Radical Gastrectomy for Gastric Cancer

NCT ID: NCT05559151

Last Updated: 2022-09-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-01

Brief Summary

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The purpose of this study is to discuss the benzene sulfonic acid red horse azole shimron the occurrence of postoperative complications in patients with gastric cancer radical and its severity, at the same time, comparing the control group (propofol) the degree of inflammation in patients with different time points difference, preliminary in this paper, the benzene sulfonic acid red horse azole shimron in gastric cancer radical viscera molecular mechanism of protection and quick recovery.

Detailed Description

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A total of 60 patients undergoing radical gastrectomy for gastric cancer were randomly divided into control group (group P) and experimental group (group R), with 30 cases in each group. Two groups are made by way of BIS target controlled infusion of anesthesia, experimental group (R group) target controlled infusion red horse azole shimron, control group (P group) target controlled infusion of propofol, BIS values are controlled in 50 + 5, postoperative observation of dynamic changes of inflammatory cytokines in plasma, postoperative adverse reactions, postoperative recovery, postoperative 30-day mortality and postoperative complications.

Through statistical analysis, it is proposed that remazolam can stabilize perioperative hemodynamic fluctuation, improve postoperative recovery, reduce the release of inflammatory mediators, reduce complications, shorten the length of hospital stay, reduce hospitalization costs, and accelerate the rapid recovery of patients with radical gastrectomy. It is proved that remazolam besylate can reduce the inflammatory response of patients undergoing radical gastrectomy, reduce the incidence of postoperative complications, and provide a favorable supplement to ERAS in patients undergoing radical gastrectomy. At the same time provide more red horse azole shimron, applied to the systemic narcotic induction and maintenance of cases and further added red horse azole shimron applied to clinical usage and dosage (by age, gender, race, obesity status, ASA grade and weight the effect of covariate), adverse reactions, and other commonly used anesthetic synergy.

Conditions

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Remimazolam Benzenesulfonate on Nenhanced Recovery After Surgery Possible Molecular Mechanism of Remimazolam Benzenesulfonate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sixty patients undergoing radical gastrectomy for gastric cancer were selected and divided into two groups according to random number table method: control group (group P) and experimental group (group R), with 30 cases in each group. All enrolled patients signed informed consent. Control group: the control group (group P) received target controlled infusion of propofol. Experimental group: the experimental group (group R) received target controlled infusion of remimazolam benzenesulfonate. And the BIS value of the two groups was controlled at 50±5.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Neither the experimenters nor the participants knew whether they were getting an experimental drug or a placebo. In this way, the description of the therapeutic effects and adverse reactions of the subjects, as well as the record of the various reactions of the experimenters, can be as objective as possible.

Study Groups

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experimental group (group R)

The experimental group (group R) received target controlled infusion of remimazolam benzenesulfonate, and the BIS value was controlled at 50±5.

Group Type EXPERIMENTAL

Remimazolam Benzenesulfonate

Intervention Type PROCEDURE

In the experimental group, remazolam 6-12mg/kg/h, atracurium cisphenylate 0.1-0.3 mg/kg and sufentanil 0.3-0.5 μg/kg were infused by micropump for anesthesia induction, and the BIS value was controlled at 50±5 before tracheal intubation.

Anesthesia maintenance: intravenous infusion of remifentanil 0.1-0.3 μg/kg/min, target controlled infusion of remifentanil in experimental group (group R), BIS value was controlled at 50±5, intermittent addition of atracurium cisphenylate to maintain muscle relaxation.

the control group (group P)

the control group (group P) received target controlled infusion of propofol, and the BIS value was controlled at 50±5.

Group Type PLACEBO_COMPARATOR

Remimazolam Benzenesulfonate

Intervention Type PROCEDURE

In the experimental group, remazolam 6-12mg/kg/h, atracurium cisphenylate 0.1-0.3 mg/kg and sufentanil 0.3-0.5 μg/kg were infused by micropump for anesthesia induction, and the BIS value was controlled at 50±5 before tracheal intubation.

Anesthesia maintenance: intravenous infusion of remifentanil 0.1-0.3 μg/kg/min, target controlled infusion of remifentanil in experimental group (group R), BIS value was controlled at 50±5, intermittent addition of atracurium cisphenylate to maintain muscle relaxation.

Interventions

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Remimazolam Benzenesulfonate

In the experimental group, remazolam 6-12mg/kg/h, atracurium cisphenylate 0.1-0.3 mg/kg and sufentanil 0.3-0.5 μg/kg were infused by micropump for anesthesia induction, and the BIS value was controlled at 50±5 before tracheal intubation.

Anesthesia maintenance: intravenous infusion of remifentanil 0.1-0.3 μg/kg/min, target controlled infusion of remifentanil in experimental group (group R), BIS value was controlled at 50±5, intermittent addition of atracurium cisphenylate to maintain muscle relaxation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China (Zhejiang) Health technology RESEARCH and development and transformation platform

UNKNOWN

Sponsor Role collaborator

Zhonghua Chen,MD

OTHER

Sponsor Role lead

Responsible Party

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Zhonghua Chen,MD

associate chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhonghua chen, master's degree

Role: CONTACT

13625751526

Facility Contacts

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zhonghua chen, master's degree

Role: primary

18279563090

Other Identifiers

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IEC-K-AF-074-1.0

Identifier Type: -

Identifier Source: org_study_id

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