A Comparison of Rocuronium 0.3 mg/kg, and 0.9 mg/kg for Induction of Anesthesia in Elderly Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2021-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia.

During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. There is a risk of residual neuromuscular block when using NMBAs like rocuronium.

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anaesthesia With or Without Rocuronium in Intubation and Intraoperative Nerve-monitoring During Thyroid Surgery.

NCT03910504

Thyroid Neuromuscular Blockade Anesthesia Complication +1 more

COMPLETED NA

Comparison of Duration of Neuromuscular Block in Geriatric Patients Compared to Young Patients.

NCT03551652

Neuromuscular Blockade

UNKNOWN

Simultaneous Injection of Propofol and Rocuronium in Inducing General Anesthesia

NCT03270696

Anesthesia; Functional

COMPLETED NA

Optimal Dose of Combination of Rocuronium and Cisatracurium

NCT02495038

Chronic Otitis Media Anesthesia

COMPLETED NA

Study of Rocuronium Onset Time According to Remifentanil Infusion

NCT01030510

Anesthesia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The number of elderly patients (\>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia within the next decades. Elderly patients are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia.

Rocuronium is a nondepolarizing neuromuscular blocking drug with an onset time of approximately 70 s and a clinical duration of action of approximately 50 min. according to previous studies. During anesthesia rocuronium is administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Rocuronium is primarily metabolized in the liver (70 % unmetabolized via the bile) and excreted via the kidneys.

Onset time and duration of action of rocuronium should be assessed by objective neuromuscular monitoring. Also, this reduces the risk of residual neuromuscular block which is defined as a train of four (TOF) ratio less than 0.9. Especially elderly patients have a high incidence of residual neuromuscular block.

The collected data regarding the effect of rocuronium in elderly patients may change the treatment so these patients receive the correct dose for optimal intubating conditions. Also, detection of duration of action of different doses of rocuronium may reduce the risk of residual block and postoperative respiratory complications

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuromuscular Blockade Neuromuscular Blockade, Residual Anesthesia Intubation Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group receiving rocuronium 0,3 mg/kg

Rocuronium 0,3 mg/kg at induction

Group Type ACTIVE_COMPARATOR

Rocuronium 0,3mg/kg

Intervention Type DRUG

Rocuronium 0,3mg/kg at induction

Group receiving rocuronium 0,9 mg/kg

Rocuronium 0,9 mg/kg at induction

Group Type ACTIVE_COMPARATOR

Rocuronium 0,9mg/kg

Intervention Type DRUG

Rocuronium 0,9mg/kg at induction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rocuronium 0,3mg/kg

Rocuronium 0,3mg/kg at induction

Intervention Type DRUG

Rocuronium 0,9mg/kg

Rocuronium 0,9mg/kg at induction

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rocuronium Rocuronium

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 80
* Scheduled to elective surgery (expected duration time of surgery \> 1 hour) under general anesthesia with intubation and use of rocuronium.
* American Society of Anesthesiologists (ASA) physical status classification I to III
* Informed consent (see appendix 1)
* Read and understand Danish