Kidney transplant sedative under the microscope
NCT ID NCT07045467
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how the sedative remimazolam behaves in the body of 30 adults receiving a kidney transplant. Researchers will measure drug levels in the blood and monitor sedation depth to ensure safe and predictable anesthesia. The goal is to gather information for better sedation practices in transplant surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Signed informed consent Age ≥18 years and \<65 years Chronic renal failure scheduled for renal transplantation Body mass index (BMI) 18-30 kg/m² (inclusive) Weight ≥50 kg (males) or ≥45 kg (females) ASA physical status classification III or IV Exclusion Criteria Hepatic, psychiatric, or neurological disorders Coagulopathy Heart failure Respiratory failure Long-term sedative or antidepressant use Pregnancy or lactation Inability to communicate or cooperate Participation in other drug/device trials within 3 months prior Positive hepatitis B surface antigen (HBsAg) Positive hepatitis C antibody (HCV-Ab) Positive HIV antibody Positive syphilis antibody Use of hepatic enzyme inhibitors/inducers within 30 days prior (per Appendix 1) Known hypersensitivity to ≥2 substances Alcohol consumption \>14 units/week within 6 months prior\* Drug abuse history within 3 months prior Major infection/trauma within 1 month prior Gastrointestinal surgery affecting drug absorption within 1 month prior Vaccination within 1 month prior or planned during study Blood loss/donation \>400 mL within 3 months prior Blood transfusion within 1 month prior INR \>1.5, PT \>ULN+4 seconds, or APTT \>15×ULN Significant bleeding history within 3 months prior Current anticoagulant therapy Any condition deemed unsuitable by investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shandong First Medical University Hospital
RECRUITINGJinan, Shangdong, 250014, China
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