Pharmacokinetics of Rocuronium for Deep Block (DeepRocu)

Neuromuscular Blockade Clinical Trial

— DeepRocu  

Official title:

Pharmacokinetics of Rocuronium (1 mg/kg) for Deep Block : a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545308
• Other study ID #: 2016-01-01
• Status: Completed
• Start date: August 25, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: June 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rocuronium is a non-depolarising neuromuscular blocking agent. The compound has a rapid onset and an intermediate duration of action.

The rapid onset is of importance in patients at risk for pulmonary aspiration, for elective induction of anesthesia. Clinical studies simulating rapid sequence induction in elective patients indicate that rocuronium 0.9 mg kg-1 may be suitable for crash intubation.Also, rocuronium may be an alternative to succinylcholine for rapid sequence induction when high dose is injected (3x Effective Dose 95 %= 1mg/kg). But, pharmacokinetic of rocuronium at 1 mg/kg is not well establish.

The investigator investigate the onset and recovery of a single dose rocuronium (1 mg/kg) in consecutive patients (>100) using adductor muscle monitoring (Train of Four and Post Tetanic Count)

Description:

In this study, pharmacokinetic of rocuronium at 1 mg/kg will be evaluated at each point of Train of Four Response (TOF) and Post Tetanic Count (when TOF=0) troughout the period of anesthesia and surgery.

Time 0 is the time of rocuronium injection, Time 1 is the time when post tetanic count is > 5-7 and TOF=0, Time 3 when TOF >0 response, Time 4 when 4 reponses of the TOF and Time 5 when TOF > 90 %

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• elective or emergency surgery under general anesthesia with deep block

• approval

• adult

Exclusion Criteria:

• contra indication to neuromuscular blockade (allergy, myopathy, hyperkaliemia)

• refusal

• < 18 years olds

• Body mass index > 50

• neuropathy

• regional anesthesia

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Rocuronium
Dose: 1 mg/kg

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset	The elapsed time (in minute) between Time 0 (injection of rocuronium) to T1 (PTC > 5-7)	3 hour
Secondary	intubation	time for intubation	1 hour
Secondary	Post Tetanic Count recovery	Times between Post Tetanic Count = 0 to 20 (Time 3)	3 hours
Secondary	Recovery Train of Four	Times between T0 to train of four= 4 (Time 4)	6 hours
Secondary	Antagonization	Evaluation of recovery with sugammadex or prostigmine	6 hours