The Effect of Propofol and Remifentanil Sequence on ED50 and ED95 of Rocuronium in Rapid Sequence Induction Anesthesia
- Conditions
- AnesthesiaNeuromuscular Blockade
- Interventions
- Registration Number
- NCT02709473
- Lead Sponsor
- Ankara University
- Brief Summary
Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway in patients especially at risk of aspiration. Propofol and rocuronium are generally used agents for RSI. However, the difficult airway scenarios are always valid for these patients, even without predictive signs of difficult airway. Therefore, it is important to decrease the rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction with the aid of a reversal agent in case of difficult airway. The short acting opioids such as remifentanil may be helpful to reduce the dose of rocuronium in RSI.
- Detailed Description
Rapid sequence induction is a widely used anesthesia technique to achieve a safe airway control. However, the difficult airway may be expected in these patients as in the others. In the difficult airway situation, cholinesterase inhibitors and sugammadex may be used for the reversal. However, sugammadex is not always available due to its cost in every hospital. In addition to this, it is well-known that cholinesterase inhibitors do not work well in case of deep neuromuscular block. In consideration of these informations, the recovery of the neuromuscular block gain an importance in patients undergoing RSI with difficult airway. Therefore, decreasing the dosage of non-depolarizing neuromuscular agent may be helpful in case of the difficult airway situations. With the aim of decreasing the neuromuscular blocker dosage, opioid analgesics especially remifentanil is preferred combined with propofol to decrease the hemodynamic response to laryngoscopy and intubation. A recent study demonstrated that after induction of anesthesia with remifentanil and propofol, ED50 of rocuronium for acceptable intubation conditions was 0.20 mg/kg. In another study, the authors showed that the administration sequence of propofol and remifentanil for target controlled anesthesia affect the onset time of rocuronium due to change in cardiac output. The authors concluded that the prior administration of remifentanil decreased the cardiac output and delayed the onset time of rocuronium.
The investigators hypothesized that prior administration of remifentanil compared to propofol may increase the ED50 and ED95 of rocuronium for acceptable intubation conditions in RSI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- American Society of Anesthesiologists (ASA) physical status I-II patients
- patients scheduled for elective surgery
- suspected or known difficult airway
- a significant renal or hepatic dysfunction
- a known neuromuscular disease
- hypertension
- a known allergy to one of the drugs used in general anesthesia
- a body mass index lower than 18.5 kg/m2 or higher than 30 kg/m2
- intake of any medication that might interact with rocuronium
- patient refusal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description propofol Propofol Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration propofol Remifentanil Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration propofol Rocuronium Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration remifentanil Propofol Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration remifentanil Remifentanil Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration remifentanil Rocuronium Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration
- Primary Outcome Measures
Name Time Method ED50 of rocuronium One minute after rocuronium injection ED50 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 50% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED50 of rocuronium will be calculated as means of drug dosage that providing acceptable intubation condition.
ED95 of rocuronium One minute after rocuronium injection ED595 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 95% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED95 of rocuronium will be estimated by using statistical tools such as pava estimator or R code.
- Secondary Outcome Measures
Name Time Method mean arterial blood pressure before and after 10 minutes of induction of anesthesia the effect of propofol and remifentanil administration sequence on mean arterial blood pressure will be evaluated.
Trial Locations
- Locations (2)
Ankara University
🇹🇷Ankara, Turkey
Harran University
🇹🇷Sanliurfa, Turkey