The Onset Time of Rocuronium in Emergency and Elective Surgery

Study Overview
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Brief Summary
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Rocuronium, a nondepolarizing neuromuscular blocking agent, is used in general anesthesia to provide conditions for endotracheal intubating. Recommended dose is 0,6 mg/kg and 90 seconds after intravenous injection, patients can be intubated. Anxiety levels may vary in patients undergoing emergency and elective surgery. Patients undergoing emergency surgery may display exaggerated laryngoscopic responses. The purpose of this study is to investigate the effect of patient anxiety levels on the onset time of rocuronium in terms of anxiety scores and train of four (TOF) 0.1 times.

Detailed Description
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After obtaining ethics committee approval, American Society of Anesthesiologists physiological status 1 (ASA 1) patients, undergoing elective inguinal hernia repair and acute appendectomy, will be included to trial. Patients will be taken to the operating room without premedication. Spielberger's State-Trait Anxiety Inventory (STAI) will be administered to patients for determining anxiety level. Electrocardiogram, blood pressure and peripheric oxygen saturation (SpO2) will be monitored. After opening intravenous access on hand dorsum, ringer lactate solution will be given. Neuromuscular monitoring and drug injections will be done as described in Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. TOF-Guard SX acceleromyograph (Organon-Teknika) will be monitored on corrugator supercilii muscle because of its sensitivity to laryngeal muscles. In induction of anesthesia, propofol 2 mg kg-1 and fentanyl 1 mcg kg-1 will be administered intravenously. After loss of conscious, TOF-Guard SX will be calibrated and then 0.6 mg kg-1 rocuronium will be administered in 5 seconds. 20 milliampere (mA) current TOF stimulation (200 ms, square wave, 2 Hz for 1.5 s) will be repeated in every 15 s. Patients will be intubated in TOF 0.1 time. STAI score, heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, SpO2, TOF 0.1 time and intubation conditions will be compared between two groups.

Official Title
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The Prospective Randomized Comparison of the Onset Time of Rocuronium in Patients Undergoing Emergency and Elective Surgery

Conditions
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Inguinal Hernia, Acute Appendicitis

Intervention / Treatment
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* Drug: Rocuronium elective surgery
* Drug: Rocuronium emergency surgery
* Drug: Propofol
* Drug: Fentanyl
* Other: Ringer Lactate
* Device: Acceleromyography device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18,5-24,9 ASA 1 Exclusion Criteria: Allergy to used drugs during anesthesia Neuromuscular disease Liver and kidney failure Heart failure Anticipated difficult airway Using aminoglycosides BMI<18,5 and BMI>25

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rocuronium elective surgery<br>patients undergoing inguinal herniorrhaphy | Drug: Rocuronium elective surgery<br>* Rocuronium onset time in patients undergoing inguinal herniorrhaphy<br>* Other names: esmeron;Drug: Propofol<br> <br> Drug: Fentanyl<br> <br> Other: Ringer Lactate<br> <br> Device: Acceleromyography device<br> <br> * Other names: TOF Guard Sx;|
| Experimental: Rocuronium emergency surgery<br>patients undergoing appendectomy | Drug: Rocuronium emergency surgery<br>* Rocuronium onset time in patients undergoing appendectomy<br>* Other names: esmeron;Drug: Propofol<br> <br> Drug: Fentanyl<br> <br> Other: Ringer Lactate<br> <br> Device: Acceleromyography device<br> <br> * Other names: TOF Guard Sx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Train of Four Ratio (TOF 0.1) |  | 90 seconds after induction | 
| anxiety score |  | 15 minutes before induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rocuronium, onset time, anxiety