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The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal Anesthesia

NCT07277881 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-06

No results posted yet for this study

Summary

This clinical trial aims to establish whether reversing remimazolam sedation with flumazenil can prevent postoperative neurocognitive disorders in patients undergoing total hip replacement surgery. The main questions it aims to answer are:

* Does administering flumazenil after surgery lead to an improvement in cognitive function (measured by the MoCA scale) at 24 hours post-operation compared to a placebo?
* Does this intervention reduce the incidence of postoperative delirium within the first 48 hours? Researchers will compare flumazenil to a placebo (0.9% saline solution) to see if actively reversing sedation leads to better cognitive outcomes and a lower incidence of delirium.

Participants will:

* Undergo a planned total hip replacement surgery under spinal anesthesia.
* Receive sedation with remimazolam during the operation.
* At the end of the surgery, receive an intravenous injection of the study drug (flumazenil) or a placebo.
* Undergo assessments for cognitive function (using the MoCA scale) and delirium (using the 4AT scale) before and at multiple time points after the surgery.
* Complete a questionnaire about their quality of recovery (QoR-15).

Conditions

  • Remimazolam
  • Hip Arthroplasty, Total
  • Sedation
  • Postoperative Delirium

Interventions

DRUG

remimazolam sedation reversal with flumazenil

Immediately after the skin suture is completed, before leaving the operating room, the patient will receive an intravenous bolus administered over 30 seconds containing the contents of a pre-prepared, coded syringe with flumazenil

DRUG

placebo

Immediately after the skin suture is completed, before leaving the operating room, the patient will receive an intravenous bolus administered over 30 seconds containing the contents of a pre-prepared, coded syringe with placebo (0,9% NaCl)

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-10-31
Completion
2028-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07277881 on ClinicalTrials.gov