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

NCT ID: NCT07277881

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-10-31

Brief 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

Postoperative Delirium; Sedation; Remimazolam; Hip Arthroplasty, Total

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Flumazenil Group

Patients will receive a single intravenous bolus of 0.5 mg of flumazenil

Group Type: EXPERIMENTAL

remimazolam sedation reversal with flumazenil

Intervention Type: DRUG

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

Placebo Group

Patients will receive a single intravenous bolus of 0.9% NaCl

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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)

Interventions

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

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient qualified for elective, primary, unilateral, total hip replacement.
• Patient assessed on the ASA I-III scale.
• MoCA score obtained during screening ≥ 23 points (to exclude patients with significant pre-existing cognitive impairment).
• Ability to understand information about the study and express informed, written consent to participate.

Exclusion Criteria

• Known hypersensitivity or allergy to benzodiazepines, flumazenil, local anesthetics
• Contraindications to spinal anesthesia or patient refusal of this anesthesia technique.
• Severe liver dysfunction.
• History of epilepsy or seizures
• Chronic (daily use for > 2 weeks in the last 3 months) use of benzodiazepines or non-benzodiazepine hypnotics (so-called "Z" drugs: zolpidem, zopiclone, zaleplon).
• Alcohol abuse defined as regular consumption of more than: in men: 40 g of pure ethanol at a time; in women: 20 g of pure ethanol at a time, or a history of psychoactive substance dependence.
• Planned revision hip arthroplasty or bilateral surgery.
• Significant neurological or psychiatric diseases that may affect the assessment of cognitive function.
• The need for sedative premedication.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Cezary Kapłan

resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

429/2025

Identifier Type: -

Identifier Source: org_study_id