Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia

NCT04965532 | Unknown

• 1 other identifier: 2020-046
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Onset time of muscle relaxation

  The first 90 min following intravenous injection of rocuronium

Other Outcomes (19)

• Clinical duration of muscle relaxation

  The first 90min following intravenous injection of rocuronium

• TOF ratio

  10min following intravenous injection of rocuronium

• T1 amplitude

  10min following intravenous injection of rocuronium

Study Arms (4)

chemotherapy patients using sevoflurane anesthesia

EXPERIMENTAL

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

chemotherapy patients using total intravenous anesthesia

ACTIVE COMPARATOR

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

nonchemotherapy patients using sevoflurane anesthesia

ACTIVE COMPARATOR

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

nonchemotherapy patient using total intravenous anesthesia

ACTIVE COMPARATOR

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

Interventions

sevoflurane anesthesia DRUG

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

Also known as: inhalation anesthesia

chemotherapy patients using sevoflurane anesthesia; nonchemotherapy patients using sevoflurane anesthesia

Propofol Injection DRUG

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

Also known as: intravenous anesthesia

chemotherapy patients using total intravenous anesthesia; nonchemotherapy patient using total intravenous anesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (2)

Huzhou Central Hospital

Huzhou, Zhejiang, 313000, China

Location

Quzhou People's Hospital

Quzhou, Zhejiang, 324002, China

Location

MeSH Terms

Interventions

Anesthesia, Inhalation; Propofol; Anesthesia, Intravenous

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Lili Fang, Dr.

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lili Fang, Dr.

CONTACT

+8615068892166; fanglili@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 16, 2021
• Study Start: September 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: August 31, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)