Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia

Chemotherapeutic Toxicity Clinical Trial

Official title:

Second Affiliated Hospital Zhejiang University School of Medicine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04965532
• Other study ID #: 2020-046
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Lili Fang, Dr.
• Phone: +8615068892166
• Email: fanglili[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity

Intervention

Drug:
• sevoflurane anesthesia
Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.
• Propofol Injection
Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.

Locations

Country	Name	City	State
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Quzhou People's Hospital	Quzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical duration of muscle relaxation	Time interval from the completion of intravenous injection of rocuronium to 25% recovery of the first twitch in the TOF stimulation pattern	The first 90min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	10min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	10min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	20min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	20min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	30min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	30min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	40min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	40min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	50min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	50min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	60min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	60min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	70min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	70min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	80min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	80min following intravenous injection of rocuronium
Other	TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	90min following intravenous injection of rocuronium
Other	T1 amplitude	The amplitude of the first twitch to TOF stimulation	90min following intravenous injection of rocuronium
Primary	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	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