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RECRUITING Not applicable ClinicalTrials.gov

TwichView-guided Atricurium Dose Adjustment Trial

Sponsor: Fu Jen Catholic University Hospital • ClinicalTrials.gov ID: NCT07807046

Registry updated: 2026-09-08
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Description

The goal of this clinical trial is to learn if using a monitor that measures muscle response can lower the amount of muscle relaxant medicine needed in adults who are treated in an intensive care unit (ICU) and need a continuous drip of a muscle relaxant called atracurium for more than 48 hours. The main questions it aims to answer are: Does using the monitor lower the infusion rate and total amount of atracurium given over 72 hours? Does using the monitor lower the complications related to atracurium use? Researchers will compare a group whose dose is guided by a muscle response monitor, aiming for a moderate level of muscle relaxation, to a group whose dose is guided by the usual bedside checks, to see if the monitor lowers the amount of medicine needed while keeping the same quality of care. Participants will: Receive atracurium as a continuous drip as part of their usual ICU treatment Have a small sensor placed on the wrist and hand to measure muscle response, if they are in the monitor group Be checked regularly by a nurse and a respiratory therapist, who will adjust the dose following a written plan Be observed closely for 72 hours, then followed until they leave the hospital .

Interventions

  • EMG-based quantitative TOF-guided atracurium titration (Device)
    Before the loading dose is given, the stimulating electrode is placed according to the protocol, and a baseline TOF measurement is obtained. A determined current of 70 mA or higher prompts electrode repositioning and repeat calibration. TOF is measured every 10 minutes during titration and every hour once the target is reached, and 10 minutes after every dose adjustment. A TOF count of 0 to 1 prompts a decrease in infusion rate, a TOF count of 2 to 3 prompts no change, and any detectable TOF ratio prompts a bolus followed by an increase in infusion rate. Adjustment increments are weight-stratified: 0.5 mL bolus and 0.5 mL per hour for participants under 80 kg, and 1 mL bolus and 1 mL per hour for participants 80 kg or over, using atracurium at 10 mg/mL. The infusion rate is capped at 20 micrograms per kilogram per minute. Titration continues for 72 hours

Eligibility criteria

Inclusion Criteria: * Adult ICU patients (≥ 20 years of age) requiring continuous atracurium infusion for more than 48 hours due to any of the following conditions: * Moderate-to-severe ARDS (PaO₂/FiO₂ ratio ≤ 150) * Post-cardiac arrest care with device-controlled TTM (intravascular or surface cooling system) * Veno-venous (VV) or veno-arterial (VA) ECMO support Exclusion Criteria: * Patients aged under 20 years * Pregnant patients * Patients with known allergy to atracurium * Patients with a do-not-intervention order due to terminal disease * Patients with severe asthma, owing to the potential for atracurium-induced histamine release * Patients or their families who refuse to participate in the trial

Conditions

ARDS TTM ECMO Neuromuscular Blockade Monitoring

Locations

  • Fu-Jen Catholic University Hospital — New Taipei City, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record