Flumazenil Antagonism of Remimazolam in Kidney Transplant Patients
NCT Number: NCT06531369
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Flumazenil to Antagonize Remimazolam|Remimazolam|Renal Transplantation
Interventions: DRUG: Flumazenil Injection（F1 group）|DRUG: Flumazenil Injection（F2 group）|DRUG: Saline（C group）
Sponsor: Qianfoshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-03

Summary:
To investigate the effect of different doses of flumazenil antagonism on remimazolam plasma concentration in patients undergoing renal transplantation under general anesthesia.

Primary Outcome Measures: Plasma Concentration of Remimazolam, 3ml arterial blood was drawn to determine the blood concentration of remimazolam, T1 (immediately at the end of surgery)|Plasma Concentration of Remimazolam, 3ml arterial blood was drawn to determine the blood concentration of remimazolam, T2 (25 minutes after the end of surgery)|Plasma Concentration of Remimazolam, 3ml arterial blood was drawn to determine the blood concentration of remimazolam, T3 (50 minutes after the end of surgery)
Secondary Outcome Measures: Record eye opening time and extubation time, Record eye opening time and extubation time, after surgery,an average of 30 minutes|remimazolam usage, remimazolam usage, immediately at the end of surgery|The amount of analgesic drugs used during operation, The amount of analgesic drugs used during operation, 3 days after surgery|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., T0（Entering the Operating Room, Before Anesthesia）|Blood Pressure (BP), Unit: millimeters of mercury (mmHg) Measurement of systolic and diastolic blood pressure upon entering the operating room, before anesthesia administration, to monitor baseline blood pressure., T0（Entering the Operating Room, Before Anesthesia）|Mean Arterial Pressure (MAP), Unit: millimeters of mercury (mmHg) Calculation of mean arterial pressure using the formula: (Systolic BP + 2\*Diastolic BP) / 3, upon entering the operating room, before anesthesia administration, to monitor baseline arterial pressure., T0（Entering the Operating Room, Before Anesthesia）|Oxygen Saturation (SpO2), Unit: percentage (%) Measurement of blood oxygen saturation upon entering the operating room, before anesthesia administration, to ensure baseline oxygenation levels., T0（Entering the Operating Room, Before Anesthesia）|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., T1(immediately at the end of surgery)|Blood Pressure (BP), Unit: millimeters of mercury (mmHg) Measurement of systolic and diastolic blood pressure upon entering the operating room, before anesthesia administration, to monitor baseline blood pressure., T1(immediately at the end of surgery)|Mean Arterial Pressure (MAP), Unit: millimeters of mercury (mmHg) Calculation of mean arterial pressure using the formula: (Systolic BP + 2\*Diastolic BP) / 3, upon entering the operating room, before anesthesia administration, to monitor baseline arterial pressure., T1(immediately at the end of surgery)|Oxygen Saturation (SpO2), Unit: percentage (%) Measurement of blood oxygen saturation upon entering the operating room, before anesthesia administration, to ensure baseline oxygenation levels., T1(immediately at the end of surgery)|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., T2（25 minutes after the end of surgery)|Blood Pressure (BP), Unit: millimeters of mercury (mmHg) Measurement of systolic and diastolic blood pressure upon entering the operating room, before anesthesia administration, to monitor baseline blood pressure., T2（25 minutes after the end of surgery)|Mean Arterial Pressure (MAP), Unit: millimeters of mercury (mmHg) Calculation of mean arterial pressure using the formula: (Systolic BP + 2\*Diastolic BP) / 3, upon entering the operating room, before anesthesia administration, to monitor baseline arterial pressure., T2（25 minutes after the end of surgery)|Oxygen Saturation (SpO2), Unit: percentage (%) Measurement of blood oxygen saturation upon entering the operating room, before anesthesia administration, to ensure baseline oxygenation levels., T2（25 minutes after the end of surgery)|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., T3（50 minutes after the end of surgery)|Blood Pressure (BP), Unit: millimeters of mercury (mmHg) Measurement of systolic and diastolic blood pressure upon entering the operating room, before anesthesia administration, to monitor baseline blood pressure., T3（50 minutes after the end of surgery)|Mean Arterial Pressure (MAP), Unit: millimeters of mercury (mmHg) Calculation of mean arterial pressure using the formula: (Systolic BP + 2\*Diastolic BP) / 3, upon entering the operating room, before anesthesia administration, to monitor baseline arterial pressure., T3（50 minutes after the end of surgery)|Oxygen Saturation (SpO2), Unit: percentage (%) Measurement of blood oxygen saturation upon entering the operating room, before anesthesia administration, to ensure baseline oxygenation levels., T3（50 minutes after the end of surgery)|Mini-Mental State Examination （MMSE )scores were obtained before, 24h and 72h after surgery, Scale Description: The MMSE is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language, and visual-spatial skills.

Unit: Score (0-30) Score Range: The MMSE score ranges from 0 to 30.

Interpretation of Scores:

Higher Scores: Indicate better cognitive function. Lower Scores: Indicate worse cognitive function.

Score Interpretation:

Cognitive Impairment:

The maximum score is 30 points. A score of 27-30 points is considered normal, while a score of \<27 points indicates cognitive impairment.

Dementia Classification Criteria:

Illiterate: ≤17 points Primary School Level: ≤20 points Secondary School Level (including technical secondary school): ≤22 points University Level (including junior college): ≤23 points

Dementia Severity Grading:

Mild: MMSE ≥21 points Moderate: MMSE 10-20 points Severe: MMSE ≤9 points

Data Collection Points:

Before Surgery (Entering the Operating Room, Before Anesthesia), Entering the Operating Room, Before Anesthesia|Mini-Mental State Examination （MMSE ）scores, Scale Description: The MMSE is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language, and visual-spatial skills.

Unit: Score (0-30) Score Range: The MMSE score ranges from 0 to 30.

Interpretation of Scores:

Higher Scores: Indicate better cognitive function. Lower Scores: Indicate worse cognitive function.

Score Interpretation:

Cognitive Impairment:

The maximum score is 30 points. A score of 27-30 points is considered normal, while a score of \<27 points indicates cognitive impairment.

Dementia Classification Criteria:

Illiterate: ≤17 points Primary School Level: ≤20 points Secondary School Level (including technical secondary school): ≤22 points University Level (including junior college): ≤23 points

Dementia Severity Grading:

Mild: MMSE ≥21 points Moderate: MMSE 10-20 points Severe: MMSE ≤9 points

Data Collection Points:

24 Hours After Surgery, 24h after the end of surgery|Mini-Mental State Examination （MMSE ）scores, Scale Description: The MMSE is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language, and visual-spatial skills.

Unit: Score (0-30) Score Range: The MMSE score ranges from 0 to 30.

Interpretation of Scores:

Higher Scores: Indicate better cognitive function. Lower Scores: Indicate worse cognitive function.

Score Interpretation:

Cognitive Impairment:

The maximum score is 30 points. A score of 27-30 points is considered normal, while a score of \<27 points indicates cognitive impairment.

Dementia Classification Criteria:

Illiterate: ≤17 points Primary School Level: ≤20 points Secondary School Level (including technical secondary school): ≤22 points University Level (including junior college): ≤23 points

Dementia Severity Grading:

Mild: MMSE ≥21 points Moderate: MMSE 10-20 points Severe: MMSE ≤9 points

Data Collection Points:

72 Hours After Surgery, 72 h after the end of surgery|Bispectral Index (BIS), This outcome measure will record and report the Bispectral Index (BIS) values. The BIS values are quantitative electroencephalographic (EEG) parameters used to assess the depth of anesthesia and sedation levels.

Bispectral Index (BIS): A value ranging from 0 to 100, where lower values indicate deeper anesthesia and higher values indicate lighter sedation or wakefulness., T0（Entering the Operating Room, Before Anesthesia）|Bispectral Index (BIS), This outcome measure will record and report the Bispectral Index (BIS) values. The BIS values are quantitative electroencephalographic (EEG) parameters used to assess the depth of anesthesia and sedation levels.

Bispectral Index (BIS): A value ranging from 0 to 100, where lower values indicate deeper anesthesia and higher values indicate lighter sedation or wakefulness., T1(immediately at the end of surgery)|Bispectral Index (BIS), This outcome measure will record and report the Bispectral Index (BIS) values. The BIS values are quantitative electroencephalographic (EEG) parameters used to assess the depth of anesthesia and sedation levels.

Bispectral Index (BIS): A value ranging from 0 to 100, where lower values indicate deeper anesthesia and higher values indicate lighter sedation or wakefulness., T2（25 minutes after the end of surgery)|Bispectral Index (BIS), This outcome measure will record and report the Bispectral Index (BIS) values. The BIS values are quantitative electroencephalographic (EEG) parameters used to assess the depth of anesthesia and sedation levels.

Bispectral Index (BIS): A value ranging from 0 to 100, where lower values indicate deeper anesthesia and higher values indicate lighter sedation or wakefulness., T3 (50 minutes after the end of surgery)|Duration of Post-Anesthesia Care Unit (PACU) Stay, Unit: Hours The total time spent in the Post-Anesthesia Care Unit (PACU) from the end of surgery until discharge to the ward., Before Leaving PACU Post-Surgery|Occurrence of nausea, Unit: Incidence (Yes/No) The occurrence of nausea during the stay in the PACU, recorded as a binary outcome (Yes or No)., 3 days after surgery|Occurrence of vomiting, Unit: Incidence (Yes/No) The occurrence of vomiting during the stay in the PACU, recorded as a binary outcome (Yes or No)., 3 days after surgery|Number of Participants with Postoperative Pulmonary Atelectasis, Cardiovascular and Cerebrovascular Adverse Events, This measure will report the number of participants who experience postoperative pulmonary atelectasis and adverse cardiovascular and cerebrovascular events, including cerebral infarction, cerebral hemorrhage, and heart infarction, within 30 days after surgery., 30 days after surgery|All-cause death within 30 days after surgery, All-cause death within 30 days after surgery, 30 days after surgery|Total hospital stay for survivors 30 days after surgery, Total hospital stay for survivors 30 days after surgery, 30 days after surgery|Unplanned second hospital admission within 30 days after surgery, Unplanned second hospital admission within 30 days after surgery, 30 days after surgery