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The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor

NCT03649672 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-01-21

No results posted yet for this study

Summary

Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia and quantitative monitoring of neuromuscular block is standard care. Normally the calibration of the neuromuscular monitor is done after anesthesia induction to avoid patient discomfort. Under certain circumstances there is no time for the calibration process. In the so-called rapid sequence induction (RSI) the neuromuscular blocking agent has to be injected immediately after the induction agent. As the neuromuscular monitor cannot be calibrated, precise neuromuscular monitoring is not possible, and this is of particular disadvantage, when high doses of non-depolarizing neuromuscular blockers are injected to fasten the onset of neuromuscular block. The primary objective is to validate the measurements of the TOF Watch SX® monitor calibrated in awake patients by comparing them with the measurements obtained with the TOF Watch SX® monitor calibrated after anesthesia induction (Gold standard).

The secondary objective is to evaluate the tolerability of the awake calibration process of the TOF Watch SX® monitor.

Conditions

  • Neuromuscular Blockade

Interventions

DEVICE

TOF Watch SX

Neuromuscular monitoring via the TOF Watch SX device

Sponsors & Collaborators

  • Hôpital du Valais

    collaborator OTHER

  • Christoph Czarnetzki

    lead OTHER

Principal Investigators

  • Christoph A Czarnetzki, MD · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-26
Primary Completion
2021-11-09
Completion
2021-11-09

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649672 on ClinicalTrials.gov