Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05725031

Enrollment

Registered

2023-02-13

Start date

2023-04-01

Completion date

2024-03-01

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rapid Sequence Induction and Intubation

Brief summary

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.

Interventions

DRUGEphedrine

70 μg/kg as pretreatment

DRUGRocuronium 0.6

0.6 mg/kg

DRUGRocuronium 0.8

0.8 mg/kg

DRUGRocuronium 1.2

1.2 mg/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intubation conditions	after 60 seconds of rocuronium administration	Evaluation of intubation conditions after rapid sequence induction using rocuronium 0.6 or 0.8 mg/kg with ephedrine pretreatment, compared with 1.2 mg/kg, according to the criteria of the Good Clinical Research Practice (GCRP) in pharmacodynamic studies of NMBAs (Fuchs-Buder et al., 2007), which assess each of the following variables for their qualities described as: (excellent, good, poor) * ease of laryngoscopy (easy, fair, difficult) * vocal cords position (abducted, intermediate, closed) * reaction to tracheal tube insertion and cuff inflation (coughing: none, slight, vigorous) The 3 variables will be combined to describe intubation conditions as: * Excellent: if all qualities are excellent * Good: if all qualities are either excellent or good * Poor: if there is a single poor quality

Secondary

Measure	Time frame	Description
Heart rate	every minute of the first 5 minutes of intubation	Following up the heart rate on the monitor
Mean arterial pressure	every minute of the first 5 minutes of intubation	Following up the mean arterial pressure by noninvasive blood pressure monitoring

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026