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

Phase 4Not Yet RecruitingNCT07277881

Medical University of Gdansk150 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

150

Conditions

Postoperative Delirium Sedation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: from baseline (preoperative) to 24 hours after surgery

Secondary Outcomes

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

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

Total duration of delirium episodes in hours

Time frame: within the first 48 hours after surgery

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

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a questionnaire consisting of 6 items graded on a 5-point Likert scale (ranging from 1 = "not at all" to 5 = "extremely"). The total score ranges from 6 to 30. A higher score indicates higher levels of preoperative anxiety.

Time frame: baseline (preoperative)

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.

Time frame: at 1 and 6 hours after surgery

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

mini-MoCA is an abbreviated version of the MoCA used for remote assessment. The total score usually ranges from 0 to 15 points. A higher score indicates better cognitive function.

Time frame: at 3 and 6 months after surgery

Quality of Recovery-15 (QoR-15) Questionnaire Score

The QoR-15 is a patient-reported outcome measure assessing the quality of recovery after anesthesia and surgery. The total score ranges from 0 to 150. A higher score indicates a better quality of recovery.

Time frame: at 24 hours after surgery

The duration of hospital stay

measured in days from the date of surgery to the date of hospital discharge.

Time frame: Assessed up to 30 days post-surgery (or through hospital discharge, whichever occurs first).

Maximum and average pain intensity measured by Numeric Rating Scale (NRS) at the following time points

Pain intensity will be assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable".

Time frame: 6, 12, 24, and 48 hours after surgery

Total oxycodone consumption (in mg)

Time frame: during the first 48 hours after surgery

Mean bispectral index (BIS) during sedation and percentage of time within the optimal range (60-80)

Time frame: during surgery

Total dose of remimazolam administered (in mg)

Time frame: during surgery

Dose of vasopressor drugs

Time frame: during surgery

Need for additional sedative drugs

Time frame: during surgery

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes