Awakening during reversal of neuromuscular block in steady state of sevoflurane anesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005851

Enrollment

106

Registered

2021-02-03

Start date

2021-04-26

Completion date

Unknown

Last updated

2023-01-10

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

Conditions

None listed

Interventions

Drug : Both group will undergo sevoflurane anesthesia for the scheduled operation and muscle relaxation will be maintained by continuous infusion of rocuronium (0.01-0.012 mg/kg/min). When the post te

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patents who have American society of anesthesiologist physical status either class I or II 2) Patients who are sheduled to elective orthopedic surgery under sevoflurane anesthesia which will take one hour or more.

Exclusion criteria

Exclusion criteria: 1) Pediatric patient under age 19. 2) Body Mass Index > 30 kg / m 2 or <18.5 kg / m 2 3) Severe liver disease 4) chronic renal disease with glomerular filtration rate under 30 mLmin-1 1.73 m-2 or on hemodialysis 5) Neuromuscular disease or mental illness 6) Those diagnosed with metabolic diseases 7) Drug addiction or alcohol addiction 8) Emergency surgery 9) Pregnant women or nursing women 10) People who have contraindications to muscle relaxants (rocuronium) and sugammadex - Patients who have allergies to drugs or have a history of hypersensitivity reactions, respiratory disease patients, arrhythmia patients 11) A person who is in the taboo of using sevoflurane - Patients with a history of allergy or hypersensitivity reactions, and malignant hyperthermia.

Design outcomes

Primary

Measure	Time frame
To compare clinical signs of awakening (ex : eye opening, cough, spontaneous movement, complete recovery, response to simple commands) depending on the degree of neuromuscular blockade (Deep NMB vs intermediate NMB)	—

Secondary

Measure	Time frame
change in bispectral index (BIS);change in BIS Electromyography (EMG) signal;change in observer's assessment of the alertness/ sedation scale;time to reach 90% of TOF ratio;duration from the administration of sugammadex to extubation;the incidence of using rescue sugammadex;satisfaction of the patients	—

Countries

Korea, Republic of

Contacts

Public ContactJeayoun Kim

Samsung Medical Center

kimjy0705@naver.com+82-2-3410-0369

Outcome results