NCT02634255

The Onset Time of Rocuronium in Emergency and Elective Surgery

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernia
• Acute Appendicitis

Interventions

Type	Name	Description
DRUG	Rocuronium elective surgery	Rocuronium onset time in patients undergoing inguinal herniorrhaphy
DRUG	Rocuronium emergency surgery	Rocuronium onset time in patients undergoing appendectomy
DRUG	Propofol
DRUG	Fentanyl
OTHER	Ringer Lactate
DEVICE	Acceleromyography device

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2015-12-18
• Last updated: 2015-12-18