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Trial Title:
Effect and Mechanism of Remimazolam Benzenesulfonate on Enhanced Recovery After Surgery in Patients Undergoing Radical Gastrectomy for Gastric Cancer
NCT ID:
NCT05559151
Condition:
Remimazolam Benzenesulfonate on Nenhanced Recovery After Surgery
Possible Molecular Mechanism of Remimazolam Benzenesulfonate
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Remimazolam Benzenesulfonate
ERAS
Radical Gastrectomy for Gastric Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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 purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Procedure
Intervention name:
Remimazolam Benzenesulfonate
Description:
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.
Arm group label:
experimental group (group R)
Arm group label:
the control group (group P)
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria: Sixty patients undergoing elective laparoscopic radical gastrectomy
for gastric cancer; aged 18-75 years; ASA≤ⅲ .
- Exclusion Criteria: Emergency surgery or non-radical gastrectomy patients; age < 18 or >
75 years old, ASA grade ≥IV. Benzodiazepines or other narcotic drug allergy patients;
patients with neurological and psychiatric disorders, long-term use of sedatives or
antidepressants; has a history of alcoholism or drug dependence; intraoperative find
distant metastasis; receive radiation and chemotherapy, cachexia; patients with a history
of other malignant tumors within five years; the patient refused to participate in the
study.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shaoxing People's Hospital
Address:
City:
Shaoxing
Zip:
312000
Country:
China
Status:
Recruiting
Contact:
Last name:
zhonghua chen, master's degree
Phone:
18279563090
Email:
429065940@qq.com
Start date:
January 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Zhonghua Chen,MD
Agency class:
Other
Collaborator:
Agency:
China (Zhejiang) Health technology RESEARCH and development and transformation platform
Agency class:
Other
Source:
Shaoxing Hospital of Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05559151
