The Prospective Randomized Comparison of the Onset Time of Rocuronium in Patients Undergoing Emergency and Elective Surgery
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Train of Four Ratio (TOF 0.1)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI 18,5-24,9
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
Arms & Interventions
Rocuronium elective surgery
patients undergoing inguinal herniorrhaphy
Intervention: Rocuronium elective surgery (Drug)
Rocuronium elective surgery
patients undergoing inguinal herniorrhaphy
Intervention: Propofol (Drug)
Rocuronium elective surgery
patients undergoing inguinal herniorrhaphy
Intervention: Fentanyl (Drug)
Rocuronium elective surgery
patients undergoing inguinal herniorrhaphy
Intervention: Ringer Lactate (Other)
Rocuronium elective surgery
patients undergoing inguinal herniorrhaphy
Intervention: Acceleromyography device (Device)
Rocuronium emergency surgery
patients undergoing appendectomy
Intervention: Rocuronium emergency surgery (Drug)
Rocuronium emergency surgery
patients undergoing appendectomy
Intervention: Propofol (Drug)
Rocuronium emergency surgery
patients undergoing appendectomy
Intervention: Fentanyl (Drug)
Rocuronium emergency surgery
patients undergoing appendectomy
Intervention: Ringer Lactate (Other)
Rocuronium emergency surgery
patients undergoing appendectomy
Intervention: Acceleromyography device (Device)
Outcomes
Primary Outcomes
Train of Four Ratio (TOF 0.1)
Time Frame: 90 seconds after induction
anxiety score
Time Frame: 15 minutes before induction
Secondary Outcomes
No secondary outcomes reported
Investigators
Gamze GULGUN
Md
Diskapi Yildirim Beyazit Education and Research Hospital
