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Clinical Trials/NCT04965532
NCT04965532
Unknown
Not Applicable

Second Affiliated Hospital Zhejiang University School of Medicine

Second Affiliated Hospital, School of Medicine, Zhejiang University2 sites in 1 country80 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
sevoflurane anesthesia
Conditions
Chemotherapeutic Toxicity
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
80
Locations
2
Primary Endpoint
Muscle relaxation recovery index
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
August 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: sevoflurane anesthesia

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.

Intervention: sevoflurane anesthesia

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.

Intervention: Propofol Injection

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.

Intervention: Propofol Injection

Outcomes

Primary Outcomes

Muscle relaxation recovery index

Time Frame: The first 90 min following intravenous injection of rocuronium

Time interval from 25% recovery to 75% recovery of the first twitch in the TOF stimulation pattern

Secondary Outcomes

  • Onset time of muscle relaxation(The first 90 min following intravenous injection of rocuronium)

Study Sites (2)

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