The Onset Time of Rocuronium in Emergency and Elective Surgery

Diskapi Yildirim Beyazit Training and Research Hospital

Status and phase: Unknown; Phase 3

Conditions: Acute Appendicitis; Inguinal Hernia

Treatments: Drug: Fentanyl; Drug: Rocuronium elective surgery; Drug: Rocuronium emergency surgery; Drug: Propofol; Other: Ringer Lactate; Device: Acceleromyography device

Study type: Interventional

Funder types: Other

Identifiers

NCT02634255

Rocuronium onset

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Rocuronium elective surgery

Active Comparator group

Description:

patients undergoing inguinal herniorrhaphy

Treatment:

Device: Acceleromyography device

Other: Ringer Lactate

Drug: Fentanyl

Drug: Propofol

Drug: Rocuronium elective surgery

Rocuronium emergency surgery

Experimental group

Description:

patients undergoing appendectomy

Treatment:

Device: Acceleromyography device

Other: Ringer Lactate

Drug: Rocuronium emergency surgery

Drug: Fentanyl

Drug: Propofol