Pharmacokinetics of Rocuronium for Deep Block (DeepRocu)

Completed

• Conditions: Neuromuscular Blockade

• Registration Number: NCT03545308
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 %

Study Timeline

• Study Start: 2017-08-25
• Study First Submitted: 2017-12-29
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-01
• Last Update Submitted: 2018-06-01
• Study First Posted: 2018-06-04
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, Gard, France