Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia

Second Affiliated Hospital Zhejiang University School of Medicine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapeutic Toxicity
• Intervention / Treatment: Drug: sevoflurane anesthesia; Drug: Propofol Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lili Fang, Dr.; Phone Number: +8615068892166; Email: fanglili@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Huzhou, Zhejiang, China, 313000
      • Huzhou Central Hospital
      • Contact: Huanzhong He, Dr.; Phone Number: 13857270631; Email: hhzhma@sina.com
    • Quzhou, Zhejiang, China, 324002
      • Quzhou people's Hospital
      • Contact: Yunping Lan, Dr.; Phone Number: 15657063766; Email: qzmzzk@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: sevoflurane anesthesia; Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.; Other Names: inhalation anesthesia
Active Comparator: 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.	Drug: Propofol Injection; Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.; Other Names: intravenous anesthesia
Active Comparator: 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.	Drug: sevoflurane anesthesia; Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.; Other Names: inhalation anesthesia
Active Comparator: 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.	Drug: Propofol Injection; Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.; Other Names: intravenous anesthesia

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	10min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	10min following intravenous injection of rocuronium
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	20min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	20min following intravenous injection of rocuronium
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	30min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	30min following intravenous injection of rocuronium
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	40min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	40min following intravenous injection of rocuronium
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	50min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	50min following intravenous injection of rocuronium
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	60min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	60min following intravenous injection of rocuronium
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	70min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	70min following intravenous injection of rocuronium
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	80min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	80min following intravenous injection of rocuronium
TOF ratio	Dividing the amplitude of the fourth response by the amplitude of the first response	90min following intravenous injection of rocuronium
T1 amplitude	The amplitude of the first twitch to TOF stimulation	90min following intravenous injection of rocuronium

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Lili Fang, Dr., Second Affiliated Hospital Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Sevoflurane
• Other Study ID Numbers: 2020-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No