The Onset Time of Rocuronium in Emergency and Elective Surgery

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02634255
• Other study ID #: Rocuronium onset
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 12, 2015
• Last updated: December 15, 2015
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2015
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Gamze Gulgun, Md
• Phone: +905308705073
• Email: dr.gamzegulgun[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis
• Emergencies
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• Rocuronium elective surgery
Rocuronium onset time in patients undergoing inguinal herniorrhaphy
• Rocuronium emergency surgery
Rocuronium onset time in patients undergoing appendectomy
• Propofol

• Fentanyl

Other:
• Ringer Lactate

Device:
• Acceleromyography device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

References & Publications (3)

Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. — View Citation

Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. — View Citation

Plaud B, Debaene B, Donati F. The corrugator supercilii, not the orbicularis oculi, reflects rocuronium neuromuscular blockade at the laryngeal adductor muscles. Anesthesiology. 2001 Jul;95(1):96-101. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Train of Four Ratio (TOF 0.1)		90 seconds after induction
Primary	anxiety score		15 minutes before induction