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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02634255
Enrollment
50
Registered
2015-12-18
Start date
2015-12-31
Completion date
2016-07-31
Last updated
2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Appendicitis, Inguinal Hernia

Keywords

rocuronium, onset time, anxiety

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.

Interventions

DRUGRocuronium elective surgery

Rocuronium onset time in patients undergoing inguinal herniorrhaphy

DRUGRocuronium emergency surgery

Rocuronium onset time in patients undergoing appendectomy

DRUGPropofol
DRUGFentanyl
OTHERRinger Lactate
DEVICEAcceleromyography device

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Train of Four Ratio (TOF 0.1)90 seconds after induction
anxiety score15 minutes before induction

Contacts

Primary ContactGamze Gulgun, Md
dr.gamzegulgun@yahoo.com+905308705073
Backup ContactDilek Yazicioglu, Md
dilek.yazicioglu@hotmail.com+905336957855

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026