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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient age ≥ 18 years old;

General anesthesia with endotracheal intubation;

Neuromuscular block with rocuronium.

Disqualifiers

Intubation before induction of anesthesia;

Critically ill patients admitted from the ICU;

Emergency cases;

Non-intubated patients;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Quantitative monitoring

    Device

    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.

  • Qualitative monitoring

    Other intervention

    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.

Treatment groups

1,032 Participants
are divided into 2 treatment groups
Group A: Quantitative monitoringExperimental treatment 1 intervention
Group B: Qualitative monitoringActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

lowest SpO2/FiO2 ratio in the PACU (constant for at least 10 minutes)

Time frame
During the time in PACU (about 30 minutes to 6 hours)

Secondary outcomes

1

Collapsed composite (any vs none) of postoperative pulmonary complications

Time frame
During length of hospital stay (about 1 day to a week)

Other outcomes

Sponsors and contacts

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