The Breath-2 Trial

Recovery of Carotid Body Function After Full Recovery Neuromuscular Block

This is a randomized, cross over, experimental trial in which carotid body function will be evaluated in 35 healthy subjects during partial muscle relaxation and after recovery from muscle relaxation

Study Overview

• Status: Recruiting
• Conditions: Peripheral Chemosensitivity
• Intervention / Treatment: Other: Muscle relaxation; Other: Reversal

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Leiden, Zuid Holland, Netherlands, 2333ZA
      • Recruiting
      • Leiden Medical University
      • Contact: Albert Dahan, MD, PhD, Professor; Phone Number: +31715262301; Email: a.dahan@lumc.nl
      • Principal Investigator: Albert Dahan, MD, PhD, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

* age > 18 years

Exclusion Criteria:

• BMI index > 30 kg/m2
• Known or suspected neuromuscular disorders impairing neuromuscular function;
• Allergies to muscle relaxants, anesthetics or narcotics;
• A (family) history of malignant hyperthermia or any other muscle disease;
• Any neurological or psychiatric illness (including a history of anxiety).
• ASA class 3 or higher
• Gastro-oesophageal regurgitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TOF ratio 0.9 spontaneous recovery; TOF ratio maintained at 0.9, spontaneous recovery	Other: Muscle relaxation; Rocuronium will be used to induce partial paralysis
Other: TOF ratio 0.7 spontaneous recovery; TOF ratio maintained at 0.7, spontaneous recovery	Other: Muscle relaxation; Rocuronium will be used to induce partial paralysis
Other: TOF ratio 0.7 low dose sugammadex; TOF ratio maintained at 0.7, reversal with sugammadex 2 mg/kg	Other: Muscle relaxation; Rocuronium will be used to induce partial paralysis; Other: Reversal; Sugamamdex will be used to reverse muscle relaxation
Other: TOF ratio 0.7 high dose sugammadex; TOF ratio maintained at 0.7, reversal with sugammadex 4 mg/kg	Other: Muscle relaxation; Rocuronium will be used to induce partial paralysis; Other: Reversal; Sugamamdex will be used to reverse muscle relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid body function after full recovery of neuromuscular block	Carotid body function will be determined by measuring acute hypoxic ventilatory response	40 minutes after full recovery of neuromuscular block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid body function at partial neuromuscular block TOF ratio 0.7	Carotid body function will be determined by measuring acute hypoxic ventilatory response	5 minutes after stable partial neuromuscular block
Carotid body function at partial neuromuscular block TOF ratio 0.9	Carotid body function will be determined by measuring acute hypoxic ventilatory response	5 minutes after stable partial neuromuscular block
Carotid body function at full recovery TOF ratio 1.0	Carotid body function will be determined by measuring acute hypoxic ventilatory response	0 minutes after full recovery of neuromuscular block
Carotid body function after full recovery of neuromuscular block	Carotid body function will be determined by measuring acute hypoxic ventilatory response	20 minutes after full recovery of neuromuscular block

Collaborators and Investigators

• Sponsor: Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: P21.083

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No