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

NCT05559151 | Unknown

• 1 other identifier: IEC-K-AF-074-1.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Remimazolam Benzenesulfonate; ERAS; Radical Gastrectomy for Gastric Cancer

Outcome Measures

Primary Outcomes (5)

• Dynamic changes of inflammatory cytokines in plasma

  Dynamic changes of inflammatory cytokines in plasma

  Before induction, 2 hours after the start of surgery, immediately after the end of surgery, 24 hours after the end of surgery, and 72 hours after the end of surgery

• Postoperative adverse reactions

  Nausea, vomiting, respiratory depression, irritability

  Within one week after surgery

• Postoperative recovery

  Postoperative resuscitation time, tracheal intubation extubation time, catheter removal time, nasogastric tube removal time, first fluid diet time, first exhaust time, first ambulation time

  Within one week after surgery

• 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

Study Arms (2)

experimental group (group R)

EXPERIMENTAL

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

Procedure: Remimazolam Benzenesulfonate

the control group (group P)

PLACEBO COMPARATOR

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

Procedure: Remimazolam Benzenesulfonate

Interventions

Remimazolam Benzenesulfonate 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.

experimental group (group R); the control group (group P)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Zhonghua Chen,MD: lead
• China (Zhejiang) Health technology RESEARCH and development and transformation platform: collaborator

Study Sites (1)

Shaoxing People's Hospital

Shaoxing, Zhejiang, 312000, China

RECRUITING

Central Study Contacts

zhonghua chen, master's degree

CONTACT

13625751526; chenbeijing116@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 29, 2022
• Study Start: January 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)