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Clinical Trials/NCT02634255
NCT02634255UnknownPhase 3

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

Diskapi Yildirim Beyazit Education and Research Hospital0 sites50 target enrollmentStarted: December 2015Last updated:
Conditions
Interventions
Drugs

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

Active Comparator

patients undergoing inguinal herniorrhaphy

Intervention: Rocuronium elective surgery (Drug)

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

Intervention: Propofol (Drug)

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

Intervention: Fentanyl (Drug)

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

Intervention: Ringer Lactate (Other)

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

Intervention: Acceleromyography device (Device)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

Intervention: Rocuronium emergency surgery (Drug)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

Intervention: Propofol (Drug)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

Intervention: Fentanyl (Drug)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

Intervention: Ringer Lactate (Other)

Rocuronium emergency surgery

Experimental

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

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Gamze GULGUN

Md

Diskapi Yildirim Beyazit Education and Research Hospital

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