Clinical trial

Intubation Conditions After Rapid Sequence Induction Using Different Doses of Rocuronium With Ephedrine Pretreatment: A Randomized Controlled Trial

Name

Eph-Roc

Description

This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII.

Trial arms

Trial start

2023-02-22

Estimated PCD

2023-07-01

Trial end

2023-09-01

Status

Recruiting

Phase

Early phase I

Treatment

Ephedrine

70 μg/kg as pretreatment

Arms:

ER6, ER8

Rocuronium 0.6

0.6 mg/kg

Arms:

ER6

Rocuronium 0.8

0.8 mg/kg

Arms:

ER8

Rocuronium 1.2

1.2 mg/kg

Arms:

R12

Size

Primary endpoint

Intubation conditions

after 60 seconds of rocuronium administration

Eligibility criteria

Inclusion Criteria: * ASA physical status I or II Exclusion Criteria: * Neuromuscular disease: myopathies * On drugs that interact with the neuromuscular junction or ephedrine * Cardiovascular disease: hypertension or ischemic heart disease * Increased risk of pulmonary aspiration: * GERD * Pregnancy * Anticipated airway difficulties: * Mallampati grade III or IV * Obesity (BMI ≥30 kg/m2), * Hypersensitivity to any of the study drugs

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2023-08-01

1 organization

2 products

1 indication

Organization

Product

Indication

Product