NCT06531369

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

June 22, 2024

Last Update Submit

July 30, 2024

Conditions

Flumazenil to Antagonize RemimazolamRemimazolamRenal Transplantation

Keywords

FlumazenilRemimazolamrenal transplantation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (33)

  • Record eye opening time and extubation time

    after surgery,an average of 30 minutes

  • remimazolam usage

    immediately at the end of surgery

  • The amount of analgesic drugs used during operation

    3 days after surgery

  • Heart Rate (HR)

    T0（Entering the Operating Room, Before Anesthesia）

  • Blood Pressure (BP)

    T0（Entering the Operating Room, Before Anesthesia）

  • +28 more secondary outcomes

Study Arms (2)

"Flumazenil group 1（F1 group）"+"Flumazenil group 2（F2 group）"

ACTIVE COMPARATOR

"Flumazenil group 1（F1）":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 group 2（F2）":Immediately after surgery, 0.5 mg flumazenil was administered, followed by 0.3 mg flumazenil 25 minutes later.

Drug: Flumazenil Injection（F1 group）Drug: Flumazenil Injection（F2 group）

Control Group (C group)

PLACEBO COMPARATOR

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.

Drug: Saline（C group）

Interventions

Flumazenil Injection（F1 group）DRUG

Flumazenil 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.

Also known as: Flumazenil at Different Dosages
"Flumazenil group 1（F1 group）"+"Flumazenil group 2（F2 group）"
Flumazenil Injection（F2 group）DRUG

Flumazenil Injection（F2 group）: Immediately after surgery, 0.5 mg flumazenil was administered, followed by 0.3 mg flumazenil 25 minutes later.

Also known as: Flumazenil at Different Dosages
"Flumazenil group 1（F1 group）"+"Flumazenil group 2（F2 group）"
Saline（C group）DRUG

Flumazenil 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.

Also known as: control group
Control Group (C group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years and \< 65 years
  • Patients undergoing elective kidney transplant surgery
  • Signed the informed consent for the clinical study

You may not qualify if:

  • 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
  • Preoperative ASA rating of 5
  • Received general anesthesia in the 30 days prior to surgery or plan to receive it again within 30 days
  • Plan to extend airway protection or mechanical ventilation support time after surgery
  • Previous participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Guanghan Wu, Attending physician

CONTACT

18763995357GuanghanWu2021@163.com

Jianbo Wu

CONTACT

13805319310jianbowu@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

June 22, 2024

First Posted

August 1, 2024

Study Start

July 1, 2024

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

August 1, 2024

Record last verified: 2024-07