Clinical trial NCT04965532: Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia
Official title: Second Affiliated Hospital Zhejiang University School of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapeutic Toxicity
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle relaxation recovery index
timeFrame: The first 90 min following intravenous injection of rocuronium
Secondary outcomes:
measure: Onset time of muscle relaxation
timeFrame: The first 90 min following intravenous injection of rocuronium
Other outcomes:
measure: Clinical duration of muscle relaxation
timeFrame: The first 90min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 10min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 10min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 20min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 20min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 30min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 30min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 40min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 40min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 50min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 50min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 60min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 60min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 70min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 70min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 80min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 80min following intravenous injection of rocuronium
measure: TOF ratio
timeFrame: 90min following intravenous injection of rocuronium
measure: T1 amplitude
timeFrame: 90min following intravenous injection of rocuronium
Locations:
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou People's Hospital
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital Zhejiang University School of Medicine
name: Lili Fang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: