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

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.

Study Overview

• Status: Recruiting
• Conditions: Rapid Sequence Induction and Intubation
• Intervention / Treatment: Drug: Ephedrine; Drug: Rocuronium 0.6; Drug: Rocuronium 0.8; Drug: Rocuronium 1.2

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amal Eldemohi; Phone Number: +201152263631; Email: amalahmed@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: Amal Eldemohi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ER6; to receive rocuronium 0.6 mg/kg with ephedrine pretreatment	Drug: Ephedrine; 70 μg/kg as pretreatment; Drug: Rocuronium 0.6; 0.6 mg/kg
Experimental: ER8; to receive rocuronium 0.8 mg/kg with ephedrine pretreatment	Drug: Ephedrine; 70 μg/kg as pretreatment; Drug: Rocuronium 0.8; 0.8 mg/kg
Active Comparator: R12; to receive rocuronium 1.2 mg/kg with no pretreatment	Drug: Rocuronium 1.2; 1.2 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neuromuscular Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium; Ephedrine
• Other Study ID Numbers: Eph-Roc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No