NCT05149872

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 11, 2025

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

November 9, 2021

Last Update Submit

February 7, 2025

Conditions

Peripheral Chemosensitivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Carotid body function at symptomatic neuromuscular block

    5 minutes after stable partial neuromuscular block

  • Carotid body function at full recovery of NMB symptoms

    0 minutes after full recovery of neuromuscular block symptoms

  • Carotid body function after full recovery of neuromuscular block

    20 minutes after full recovery of neuromuscular block symptoms

  • Carotid body function after full recovery of neuromuscular block

    40 minutes after full recovery of neuromuscular block symptoms

Study Arms (3)

spontaneous recovery

OTHER

Spontaneous recovery

Other: Muscle relaxation

reversal with sugammadex 2 mg/kg

OTHER

reversal with sugammadex 2 mg/kg

Other: Muscle relaxationOther: Reversal

reversal with sugammadex 4 mg/kg

OTHER

reversal with sugammadex 4 mg/kg

Other: Muscle relaxationOther: Reversal

Interventions

Muscle relaxationOTHER

Rocuronium will be used to induce partial paralysis

reversal with sugammadex 2 mg/kgreversal with sugammadex 4 mg/kgspontaneous recovery
ReversalOTHER

Sugamamdex will be used to reverse muscle relaxation

reversal with sugammadex 2 mg/kgreversal with sugammadex 4 mg/kg

Eligibility Criteria

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

You may qualify if:

  • \* age \> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden Medical University

Leiden, South Holland, 2333ZA, Netherlands

Location

MeSH Terms

Interventions

Muscle Relaxation

Intervention Hierarchy (Ancestors)

Muscle ContractionMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 9, 2021

First Posted

December 8, 2021

Study Start

August 15, 2022

Primary Completion

November 1, 2022

Study Completion

April 1, 2023

Last Updated

February 11, 2025

Record last verified: 2024-10

Locations

NL(1)