Recruiting

Observational Study

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT06236763

Conditions

Neuromuscular Blockade

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

TOFscan foot

Study Details

Brief summary:

Gold standard for neuromuscular blockade evaluation is accelerometry in three dimensions at the thumb. There are many times that measurement at the hand can be falsely under-estimated intraoperatively secondary to constriction of the upper extremities. We believe that installing the same accelerometer at the first toe will give us similar readings for both neuromuscular blockade and recovery from rocuronium administration. This study focuses on agreement values between two accelerometers installed on the hand and at on the foot.

Conditions

Neuromuscular Blockade

Study ID

NCT06236763

Start date

Mar 1, 2024

Status verified date

Mar, 2024

Completion date

Jul 1, 2024

Anticipated

Primary completion date

Apr 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ASA 1-3 patients
  • Elective surgery
  • Undergoing general anesthesia with rocuronium induced NMB
  • BMI < 36 kg.m-2
  • Age > 18 years old
  • French or English speaking patient

Exclusion Criteria:

  • Renal or hepatic dysfunction
  • Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine
  • Neuromuscular disease
  • Peripheral arterial disease (suspected, known or investigated)
  • Calcium channel anomalies
  • Hypothermia (< 35C)
  • Hyper/hypomagnasemia
  • Allergy to any drug used in the study protocol
  • Patient refusal

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Observation and control

Two accelerometers will be applied on each patient; observation (foot) and control (hand, also the gold standard). Agreement values will be compared between these two monitors.

Interventions

TOFscan foot

TOFscan will be applied on the foot and recovery from neuromuscular blockade will be observed over time. These will be compared with the control (TOFscan at the hand) on the same patient (gold standard monitor).

Primary outcome measure

  • Time of neuromuscular blockade (NMB) recovery [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Louis-Philippe Fortier, MD

514-252-3426lpfortier.hmr@ssss.gouv.qc.ca

Nadia Godin

514-252-3426ngodin.hmr@ssss.gouv.qc.ca

Locations

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Ile de Montréal

Recruiting

Montréal, Quebec, Canada, H1T 2M4

Contacts

Louis-Philippe Fortier, MD

514-252-3426lpfortier.hmr@ssss.gouv.qc.ca

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Mar 8, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2024-03-08.