Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation

Surgery Clinical Trial

— DBS PREDICTION  

Official title:

Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02893436
• Other study ID #: PSS2014/DBSPREDICTION-SCHMARTZ
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2016
• Last updated: September 2, 2016
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: Denis Schmartz
• Email: d.schmartz[@]chru-nancu.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.

Description:

Neuromuscular monitoring is a basic monitoring for all curarised patients. Acceleromiography is used to supervise neuromuscular blockade and allow measuring in an objective and quantitative manner the curarisation level during surgery and phase of recovery from neuromuscular blockade. Various parameters are usually measured during surgery:

• T4/T1 ratio: ratio between the 4th and 1st response to "train of four" stimulation (TOF, 4 stimulations of 0.2 ms in 2 s). Neuromuscular recovery is considered appropriate if T4/T1 ratio is > 0.9

• Double burst stimulation (DBS): 2 short tetanic stimulations separated by an interval of 750 ms.

It is known that when DBSs induce the same visual and/or tactile response, T4/T1 recovery time is > 0.6. However, for an optimal recovery, T4/T1 ratio must be > 0.9.

This study will analyze the interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9, from anesthesia sheet of patients undergone surgery with tracheal intubation curarisation.

Results will define a minimum time to have an optimal recovery after having visually identical DBS responses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA score 1-3

• Needing a surgery with tracheal intubation curarisation

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

Procedure:
• Surgery with tracheal intubation curarisation

Locations

Country	Name	City	State
France	CHRU Nancy	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9	measured with TOF-Watch Sx	day 0	No