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

NCT07277881 | Not Yet Recruiting Phase 4

• 1 other identifier: 429/2025
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change in Montreal Cognitive Assessment (MoCA) score

  The MoCA is a cognitive screening tool. The total score ranges from 0 to 30 points. A higher score indicates better cognitive function.

  from baseline (preoperative) to 24 hours after surgery

Secondary Outcomes (13)

• Incidence of delirium (defined as a score of ≥ 4 on the 4AT scale)

  within the first 48 hours after surgery, assessed every 6 hours.

• Total duration of delirium episodes in hours

  within the first 48 hours after surgery

• Preoperative Anxiety Level assessed by Amsterdam Preoperative Anxiety and Information Scale (APAIS)

  baseline (preoperative)

• Montreal Cognitive Assessment (MoCA) score

  at 1 and 6 hours after surgery

• Mini Montreal Cognitive Assessment (mini-MoCA) scores (telephone assessment)

  at 3 and 6 months after surgery

Study Arms (2)

Flumazenil Group

EXPERIMENTAL

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

Drug: remimazolam sedation reversal with flumazenil

Placebo Group

PLACEBO COMPARATOR

Patients will receive a single intravenous bolus of 0.9% NaCl

Drug: placebo

Interventions

remimazolam sedation reversal with flumazenil 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

Flumazenil Group

placebo 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)

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Gdansk: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Flumazenil

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01