Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment
- Conditions
- Rapid Sequence Induction and Intubation
- Interventions
- Registration Number
- NCT05725031
- Lead Sponsor
- Ain Shams University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- ASA physical status I or II
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R12 Rocuronium 1.2 to receive rocuronium 1.2 mg/kg with no pretreatment ER8 Ephedrine to receive rocuronium 0.8 mg/kg with ephedrine pretreatment ER8 Rocuronium 0.8 to receive rocuronium 0.8 mg/kg with ephedrine pretreatment ER6 Rocuronium 0.6 to receive rocuronium 0.6 mg/kg with ephedrine pretreatment ER6 Ephedrine to receive rocuronium 0.6 mg/kg with ephedrine pretreatment
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mean arterial pressure every minute of the first 5 minutes of intubation Following up the mean arterial pressure by noninvasive blood pressure monitoring
Heart rate every minute of the first 5 minutes of intubation Following up the heart rate on the monitor
Trial Locations
- Locations (1)
Ain Shams University Hospitals
🇪🇬Cairo, Egypt