Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-08-31

Brief Summary

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

Chemotherapy causes motor nerve dysfunction and degeneration that may alter the response to neuromuscular blocking drugs. To analyse the risk of residual neuromuscular block (RNMB) induced by rocuronium given in standard doses to patients who undergo chemotherapy within three months.

Related Clinical Trials

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

Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium

NCT02785653

Muscle Relaxation Caused by Sevoflurane

COMPLETED PHASE4

Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision

NCT00575354

Breast Neoplasms

COMPLETED PHASE4

Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

NCT03841812

Nociceptive Pain Analgesic Adverse Reaction Inhalant Use

COMPLETED PHASE3

Three Different Doses of Neostigmine on the Reversal of Cisatracurium-induced Moderate Neuromuscular Blockade

NCT05037006

Neuromuscular Blockade Neuromuscular Blockade, Residual

UNKNOWN PHASE4

Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram

NCT01662622

Middle Aged Patients Sevoflurane General Anesthesia

COMPLETED PHASE4

Detailed Description

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

Rocuronium, as a non depolarizing muscle relaxant with medium time effect, takes effect rapidly. It is an ideal neuromuscular blocker to replace succinylcholine for induction of tracheal intubation and maintenance of muscle relaxant under general anesthesia. Sevoflurane is widely used in clinic because of its low blood gas partition coefficient, rapid and stable induction and recovery, easy adjustment of anesthesia depth and strong controllability. In addition, the number of patients receiving preoperative adjuvant chemotherapy for malignant tumors is increasing year by year in China. The commonly used chemotherapy drugs, such as paclitaxel, platinum, vinorelbine, etc., have dose-dependent peripheral neurotoxicity. Therefore, to explore and study the influence of pathophysiological changes of patients receiving chemotherapy on the neuromuscular relaxation effect of sevoflurane combined with non depolarizing neuromuscular blockers, It is very important for anesthesia, resuscitation and perioperative management of chemotherapy patients. The purpose of this study is to reveal the effect of sevoflurane on rocuronium neuromuscular blockade in chemotherapy patients by comparing the difference of rocuronium neuromuscular blockade effect of sevoflurane and total intravenous anesthesia in chemotherapy patients and non chemotherapy patients, and to provide information for more safe and rational application of rocuronium in clinical anesthesia of chemotherapy patients.

Conditions

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

Chemotherapeutic Toxicity

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

Eighty patients undergoing liver radiofrequency ablation surgery under elective general anesthesia were selected, of whom 40 received preoperative adjuvant chemotherapy and the other 40 were nonchemotherapy patients, who were divided by randomization according to the method of anesthesia maintenance, respectively.Chemotherapy patients were divided into PC group with 20 cases using all intravenous anesthesia and SC group with 20 cases using sevoflurane anesthesia.The nonchemotherapy patients were divided into PN group with 20 cases using all intravenous anesthesia and Sn group with 20 cases using sevoflurane anesthesia.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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

chemotherapy patients using sevoflurane anesthesia

Following induction of anesthesia and laryngeal mask placement, anesthesia will be maintained by inhalation of sevoflurane (approximately 1.3 × minimum alveolar concentration) and IV fentanyl according to clinical need.

Group Type EXPERIMENTAL

sevoflurane anesthesia

Intervention Type DRUG

Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.

chemotherapy patients using total intravenous anesthesia

Following induction of anesthesia and laryngeal mask placement, maintenance of anesthesia will consist of target-controlled infusion of propofol at a plasma target concentration of 1.5-3.0µg/ml and IV fentanyl according to clinical need.

Group Type ACTIVE_COMPARATOR

Propofol Injection

Intervention Type DRUG

Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.

nonchemotherapy patients using sevoflurane anesthesia

Following induction of anesthesia and laryngeal mask placement, anesthesia will be maintained by inhalation of sevoflurane (approximately 1.3 × minimum alveolar concentration) and IV fentanyl according to clinical need.

Group Type ACTIVE_COMPARATOR

sevoflurane anesthesia

Intervention Type DRUG

Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.

nonchemotherapy patient using total intravenous anesthesia

Following induction of anesthesia and laryngeal mask placement, maintenance of anesthesia will consist of target-controlled infusion of propofol at a plasma target concentration of 1.5-3.0µg/ml and IV fentanyl according to clinical need.

Group Type ACTIVE_COMPARATOR

Propofol Injection

Intervention Type DRUG

Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.

Interventions

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

sevoflurane anesthesia

Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.

Intervention Type DRUG

Propofol Injection

Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.

Intervention Type DRUG

Other Intervention Names

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

inhalation anesthesia intravenous anesthesia

Eligibility Criteria

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

Inclusion Criteria

* Patients classified as American Society of Anesthesiology physical status (ASA PS) classes I, II or III
* Aged between 18 and 70 years
* Scheduled for radiofrequency ablation of liver tumours under general anaesthesia with an expected surgery duration shorter than 60min

Exclusion Criteria

* Allergy to rocuronium
* Myasthenia gravis
* Guillain-Barre ́ syndrome
* Duchenne muscular dystrophy or similar
* Receiving drugs that might interfere with the neuromuscular transmission or the response to neuromuscular blockers, such as some anticonvulsants and antibiotics

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No