Quantitative Versus qUAlitative NeuromoniToring of neUroMuscular Block for Non-cardiothoracic Surgery

Purpose

The purpose of this study is to assess the effect of quantitative block monitoring versus less expensive qualitative monitoring treatment effects on the lowest SpO2/FiO2 ratio in the PACU. The results will be incorporated into an enhanced recovery pathway for surgical patients.

Condition

  • Neuromuscular Block, Residual

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient age ≥ 18 years old; - General anesthesia with endotracheal intubation; - Neuromuscular block with rocuronium.

Exclusion Criteria

  • Intubation before induction of anesthesia; - Critically ill patients admitted from the ICU; - Emergency cases; - Non-intubated patients; - Patients who will not be paralyzed through the surgery (spine). - Patients with an implanted electronic device (e.g. cardiac pacemaker) - Patients with allergies to adhesive - Patients with pre-existing neuromuscular disease (e.g. Myasthenia Gravis)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Designated operating rooms of the hospital will be cluster randomized in this study. For each week of the 24-week trial, the designated operating rooms will be randomized to either quantitative or qualitative TOF monitoring.
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Quantitative monitoring
  • Device: Quantitative monitoring
    The TetraGraph TOF monitor will be used to quantitatively assess the TOF-ratio. Quantitative monitoring includes objective measurement of the TOF-ratio, as defined by the ratio between the first and the fourth muscular responses and is quantified by acceleromyography. A TOF twitch response ratio equal or greater to 95% (TOF0.95) will be targeted prior to extubation. If TOF0.95 is not reached within 10 min of administering the initial dose of the respective reversal agent, redosing is recommended.
Active Comparator
Qualitative monitoring
  • Other: Qualitative monitoring
    Clinicians will assess the TOF-ratio. Qualitative monitoring includes subjective assessment of the count and the amplitude of the muscular responses related to neuromuscular block depth. A TOF twitch response count of 4 similarly strong twitches will be targeted prior to extubation. If 4 similarly strong TOF twitch responses are not reached within 10 min of administering the initial dose of the respective reversal agent, redosing is recommended.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
Contact:
Mehmet Turan, MD
713-500-6251
Mehmet.A.Turan@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Mehmet Turan, MD
(713) 500-6251
Mehmet.A.Turan@uth.tmc.edu