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The Onset Time of Rocuronium in Emergency and Elective Surgery

Phase 3
Conditions
Inguinal Hernia
Acute Appendicitis
Interventions
Registration Number
NCT02634255
Lead Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Rocuronium elective surgeryRocuronium elective surgerypatients undergoing inguinal herniorrhaphy
Rocuronium elective surgeryPropofolpatients undergoing inguinal herniorrhaphy
Rocuronium elective surgeryFentanylpatients undergoing inguinal herniorrhaphy
Rocuronium elective surgeryRinger Lactatepatients undergoing inguinal herniorrhaphy
Rocuronium elective surgeryAcceleromyography devicepatients undergoing inguinal herniorrhaphy
Rocuronium emergency surgeryRocuronium emergency surgerypatients undergoing appendectomy
Rocuronium emergency surgeryRinger Lactatepatients undergoing appendectomy
Rocuronium emergency surgeryAcceleromyography devicepatients undergoing appendectomy
Rocuronium emergency surgeryFentanylpatients undergoing appendectomy
Rocuronium emergency surgeryPropofolpatients undergoing appendectomy
Primary Outcome Measures
NameTimeMethod
Train of Four Ratio (TOF 0.1)90 seconds after induction
anxiety score15 minutes before induction
Secondary Outcome Measures
NameTimeMethod
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