Intubation Conditions After RSI Using Rocuronium With Ephedrine Pretreatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Rapid Sequence Induction and Intubation

Intervention / Treatment
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* Drug: Ephedrine
* Drug: Rocuronium 0.6
* Drug: Rocuronium 0.8
* Drug: Rocuronium 1.2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |