NCT03649672

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 26, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

August 24, 2018

Last Update Submit

January 10, 2022

Conditions

Neuromuscular Blockade

Keywords

Tof Watch, rocuronium

Outcome Measures

Primary Outcomes (1)

  • Total recovery time

    Total duration of the neuromuscular block defined as the time in minutes from start of injection of rocuronium until a normalized TOF ratio of 90%

    during the duration of the general anesthesia

Secondary Outcomes (6)

  • Onset time

    during the duration of the general anesthesia

  • Dur TOFc1

    during the duration of the general anesthesia

  • Dur TOF 25%

    during the duration of the general anesthesia

  • Dur TOF 50%

    during the duration of the general anesthesia

  • Dur TOF 75%

    during the duration of the general anesthesia

  • +1 more secondary outcomes

Study Arms (2)

Awake calibration

EXPERIMENTAL

The dominant arm of the patient

Device: TOF Watch SX

Asleep calibration

ACTIVE COMPARATOR

The non dominant arm of the patient

Device: TOF Watch SX

Interventions

TOF Watch SXDEVICE

Neuromuscular monitoring via the TOF Watch SX device

Asleep calibrationAwake calibration

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists class I or II
  • patients undergoing elective surgery lasting at least 60 minutes under general anesthesia requiring neuromuscular blockade using rocuronium bromide for endotracheal intubation

You may not qualify if:

  • Patient with a history of allergy or hypersensitivity to rocuronium.
  • Patients with neuromuscular disease
  • Patients with preoperative medications known to influence neuromuscular function (for instance aminoglycosides, phenytoin, lidocaine)
  • Patients with electrolyte abnormalities (for instance, hypermagnesemia)
  • Patients with a body mass index \<19 or \>30 kg m2
  • Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial
  • Patients undergoing interventions that need a continuous deep neuromuscular block
  • Pregnant or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Geneva, Anesthesia Department

Geneva, Canton of Geneva, 1211, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, Canton Ticino, 6900, Switzerland

Location

Study Officials

  • Christoph A Czarnetzki, MD

    University Hospital, Geneva

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Neuromuscular monitoring by TOF Watch SX on the dominant and on the non dominant arm
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, MBA

Study Record Dates

First Submitted

August 24, 2018

First Posted

August 28, 2018

Study Start

October 26, 2018

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

CH(2)