Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment

NCT05725031 | Completed Phase 3

• 1 other identifier: Eph-Roc
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Rapid Sequence Induction and Intubation

Outcome Measures

Primary Outcomes (1)

• Intubation conditions

  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

  after 60 seconds of rocuronium administration

Secondary Outcomes (2)

• Heart rate

  every minute of the first 5 minutes of intubation

• Mean arterial pressure

  every minute of the first 5 minutes of intubation

Study Arms (3)

ER6

EXPERIMENTAL

to receive rocuronium 0.6 mg/kg with ephedrine pretreatment

Drug: Ephedrine; Drug: Rocuronium 0.6

ER8

EXPERIMENTAL

to receive rocuronium 0.8 mg/kg with ephedrine pretreatment

Drug: Ephedrine; Drug: Rocuronium 0.8

R12

ACTIVE COMPARATOR

to receive rocuronium 1.2 mg/kg with no pretreatment

Drug: Rocuronium 1.2

Interventions

Ephedrine DRUG

70 μg/kg as pretreatment

ER6; ER8

Rocuronium 0.6 DRUG

0.6 mg/kg

ER6

Rocuronium 0.8 DRUG

0.8 mg/kg

ER8

Rocuronium 1.2 DRUG

1.2 mg/kg

R12

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I or II

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Ephedrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 13, 2023
• Study Start: April 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)