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Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia

Second Affiliated Hospital Zhejiang University School of Medicine

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04965532
Enrollment
80
Registered
2021-07-16
Start date
2021-09-01
Completion date
2022-08-31
Last updated
2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapeutic Toxicity

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.

Interventions

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

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle relaxation recovery indexThe first 90 min following intravenous injection of rocuroniumTime interval from 25% recovery to 75% recovery of the first twitch in the TOF stimulation pattern

Secondary

MeasureTime frameDescription
Onset time of muscle relaxationThe first 90 min following intravenous injection of rocuroniumTime interval from the completion of intravenous injection of rocuronium to the maximal depression of the first twitch in the TOF stimulation pattern

Other

MeasureTime frameDescription
Clinical duration of muscle relaxationThe first 90min following intravenous injection of rocuroniumTime interval from the completion of intravenous injection of rocuronium to 25% recovery of the first twitch in the TOF stimulation pattern
TOF ratio10min following intravenous injection of rocuroniumDividing the amplitude of the fourth response by the amplitude of the first response
T1 amplitude10min following intravenous injection of rocuroniumThe amplitude of the first twitch to TOF stimulation

Countries

China

Contacts

Primary ContactLili Fang, Dr.
fanglili@zju.edu.cn+8615068892166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026