Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Second Affiliated Hospital Zhejiang University School of Medicine

Conditions
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Chemotherapeutic Toxicity

Intervention / Treatment
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* Drug: sevoflurane anesthesia
* Drug: Propofol Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemotherapy patients using sevoflurane anesthesia<br>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. | Drug: sevoflurane anesthesia<br>* Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.<br>* Other names: inhalation anesthesia;|
| Active Comparator: chemotherapy patients using total intravenous anesthesia<br>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. | Drug: Propofol Injection<br>* Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.<br>* Other names: intravenous anesthesia;|
| Active Comparator: nonchemotherapy patients using sevoflurane anesthesia<br>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. | Drug: sevoflurane anesthesia<br>* Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.<br>* Other names: inhalation anesthesia;|
| Active Comparator: nonchemotherapy patient using total intravenous anesthesia<br>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. | Drug: Propofol Injection<br>* Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.<br>* Other names: intravenous anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle relaxation recovery index | Time interval from 25% recovery to 75% recovery of the first twitch in the TOF stimulation pattern | The first 90 min following intravenous injection of rocuronium | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time of muscle relaxation | Time interval from the completion of intravenous injection of rocuronium to the maximal depression of the first twitch in the TOF stimulation pattern | The first 90 min following intravenous injection of rocuronium |