Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Rapid Sequence Induction and Intubation

Treatments: Drug: Rocuronium 0.6; Drug: Rocuronium 1.2; Drug: Rocuronium 0.8; Drug: Ephedrine

Study type: Interventional

Funder types: Other

Identifiers

NCT05725031

Eph-Roc

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

ER6

Experimental group

Description:

to receive rocuronium 0.6 mg/kg with ephedrine pretreatment

Treatment:

Drug: Ephedrine

Drug: Rocuronium 0.6

ER8

Experimental group

Description:

to receive rocuronium 0.8 mg/kg with ephedrine pretreatment

Treatment:

Drug: Ephedrine

Drug: Rocuronium 0.8

R12

Active Comparator group

Description:

to receive rocuronium 1.2 mg/kg with no pretreatment

Treatment:

Drug: Rocuronium 1.2