Flumazenil Antagonism of Remimazolam in Kidney Transplant Patients
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorQianfoshan Hospital
About this trial
To investigate the effect of different doses of flumazenil antagonism on remimazolam plasma concentration in patients undergoing renal transplantation under general anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and < 65 years
Patients undergoing elective kidney transplant surgery
Signed the informed consent for the clinical study
Disqualifiers
Liver decompensation (Child B/C)
History of liver transplant
Previous allergies or other serious adverse reactions to narcotic drugs
Intraoperative depth monitoring of anesthesia is not expected
Trial design
Design model
Parallel
Treatments tested in this trial
Flumazenil Injection（F1 group）
DrugFlumazenil Injection（F1 group）: Immediately after surgery, 0.5 mg flumazenil was administered, followed by an equal volume of saline (equal to the volume of 0.3 mg flumazenil) 25 minutes later.
Flumazenil Injection（F2 group）
DrugFlumazenil Injection（F2 group）: Immediately after surgery, 0.5 mg flumazenil was administered, followed by 0.3 mg flumazenil 25 minutes later.
Saline（C group）
DrugFlumazenil Injection（F2 group）: Immediately after surgery, an equal volume of saline (equal to the volume of 0.5 mg flumazenil) was administered, followed by an equal volume of saline (equal to the volume of 0.3 mg flumazenil) 25 minutes later.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: "Flumazenil group 1（F1 group）"+"Flumazenil group 2（F2 group）"Active comparator 2 interventions
Group B: Control Group (C group)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Plasma Concentration of Remimazolam
3ml arterial blood was drawn to determine the blood concentration of remimazolam
Time frame
T1 (immediately at the end of surgery)2
Plasma Concentration of Remimazolam
3ml arterial blood was drawn to determine the blood concentration of remimazolam
Time frame
T2 (25 minutes after the end of surgery)3
Plasma Concentration of Remimazolam
3ml arterial blood was drawn to determine the blood concentration of remimazolam
Time frame
T3 (50 minutes after the end of surgery)Secondary outcomes
1
Record eye opening time and extubation time
Record eye opening time and extubation time
Time frame
after surgery,an average of 30 minutes2
remimazolam usage
remimazolam usage
Time frame
immediately at the end of surgery3
The amount of analgesic drugs used during operation
The amount of analgesic drugs used during operation
Time frame
3 days after surgery4
Heart Rate (HR)
Unit: beats per minute (bpm) Measurement of heart rate upon entering the operating room, before anesthesia administration, to monitor baseline cardiac activity.
Time frame
T0（Entering the Operating Room, Before Anesthesia）Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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