Pharmacokinetics of Rocuronium for Deep Block (DeepRocu)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03545308

Acronym

DeepRocu

Enrollment

250

Registered

2018-06-04

Start date

2017-08-25

Completion date

2018-03-01

Last updated

2018-06-04

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

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular, Deep Anesthesia, Rocuronium

Brief 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)

Detailed 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 %

Interventions

DRUGRocuronium

Dose: 1 mg/kg

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Onset	3 hour	The elapsed time (in minute) between Time 0 (injection of rocuronium) to T1 (PTC \> 5-7)

Secondary

Measure	Time frame	Description
intubation	1 hour	time for intubation
Post Tetanic Count recovery	3 hours	Times between Post Tetanic Count = 0 to 20 (Time 3)
Recovery Train of Four	6 hours	Times between T0 to train of four= 4 (Time 4)
Antagonization	6 hours	Evaluation of recovery with sugammadex or prostigmine

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026