Reversal of Residual Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine
- Conditions
- Neuromuscular Blockade
- Interventions
- Registration Number
- NCT03656614
- Lead Sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Brief Summary
The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.
- Detailed Description
Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- 1 age of 18 to 65 yr,
- 2 body mass index 18.5 to 25.0 kg/m2,
- 3 American Society of Anesthesiologists physical status I to III
- 4 scheduled for elective surgery with an expected duration of at least 60min under general anesthesia with intubation of the trachea or laryngeal mask
- 5 patients having given informed consent to the study
- 1 patients who had participated in another clinical trial within 1 month
- 2 Patients with suspected difficult airway, bronchial asthma, chronic obstructive pulmonary disease
- 3 known neuromuscular disease
- 4 suspected malignant hyperthermia
- 5 hepatic or renal dysfunction
- 6 glaucoma
- 7 allergy to the medication that used in this trial
- 8 taking medicaments that might influence the effect of NMB agents
- 9 pregnant, or breastfeeding state
- 10 taking medication known to alter the effect of neuromuscular blocking agents( toremifene .etc)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sugammadex 0.5 Sugammadex Sugammadex group: sugammadex 0.5 mg/kg IV once at the reappearance of TOF 0.3 sugammadex 0.125 Sugammadex Sugammadex group: sugammadex 0.125 mg/kg IV once at the reappearance of TOF 0.3 Sugammadex 0.25 Sugammadex Sugammadex group: sugammadex 0.25 mg/kg IV once at the reappearance of TOF 0.3 Sugammadex 1.0 Sugammadex Sugammadex group: sugammadex 1.0 mg/kg IV once at the reappearance of TOF 0.3 Sugammadex 2.0 Sugammadex Sugammadex group: sugammadex 2.0 mg/kg IV once at the reappearance of TOF 0.3 Neostigmine 55 Neostigmine Neostigmine group: neostigmine 55 µg/kg IV once at the reappearance of TOF 0.3 Placebo Saline 0.9% Placebo group: Saline 0.9% IV once at the reappearance of TOF 0.3 Neostigmine 10 Neostigmine Neostigmine group: neostigmine 10 µg/kg IV once at the reappearance of TOF 0.3 Neostigmine 25 Neostigmine Neostigmine group: neostigmine 25 µg/kg IV once at the reappearance of TOF 0.3 Neostigmine 40 Neostigmine Neostigmine group: neostigmine 40 µg/kg IV once at the reappearance of TOF 0.3 Neostigmine 70 Neostigmine Neostigmine group: neostigmine 70 µg/kg IV once at the reappearance of TOF 0.3
- Primary Outcome Measures
Name Time Method Time to TOF 0.9 after the administration of reversal agent the general anesthesia time 1 hour at least The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration.
- Secondary Outcome Measures
Name Time Method incidence of reparalysis approximately 1 hour Determining whether patients receiving reversal agent will have a train-to-four ratio \<0.8 during total recovery time (from TOF reach 0.9 first time to post-anaesthesia care unit (PACU) departure)
incidence of adverse event the general anesthesia and recovery time 2 hours at least Documenting whether patients will have some adverse events(such as hypoxia bradycardia nausea and vomiting) from anesthesia commence to PACU departure.
Trial Locations
- Locations (1)
Guangzhou Military Region General Hospital, Department of Anesthesiology
🇨🇳Guangzhou, Guangdong, China