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The Onset Time of Rocuronium in Emergency and Elective Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02634255
Recruitment Status : Unknown
Verified December 2015 by Gamze GULGUN, Diskapi Yildirim Beyazit Education and Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Gamze GULGUN, Diskapi Yildirim Beyazit Education and Research Hospital

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.


Condition or disease Intervention/treatment Phase
Inguinal Hernia Acute Appendicitis Drug: Rocuronium elective surgery Drug: Rocuronium emergency surgery Drug: Propofol Drug: Fentanyl Other: Ringer Lactate Device: Acceleromyography device Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Prospective Randomized Comparison of the Onset Time of Rocuronium in Patients Undergoing Emergency and Elective Surgery
Study Start Date : December 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Rocuronium elective surgery
patients undergoing inguinal herniorrhaphy
Drug: Rocuronium elective surgery
Rocuronium onset time in patients undergoing inguinal herniorrhaphy
Other Name: esmeron

Drug: Propofol
Drug: Fentanyl
Other: Ringer Lactate
Device: Acceleromyography device
Other Name: TOF Guard Sx

Experimental: Rocuronium emergency surgery
patients undergoing appendectomy
Drug: Rocuronium emergency surgery
Rocuronium onset time in patients undergoing appendectomy
Other Name: esmeron

Drug: Propofol
Drug: Fentanyl
Other: Ringer Lactate
Device: Acceleromyography device
Other Name: TOF Guard Sx




Primary Outcome Measures :
  1. Train of Four Ratio (TOF 0.1) [ Time Frame: 90 seconds after induction ]
  2. anxiety score [ Time Frame: 15 minutes before induction ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634255


Contacts
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Contact: Gamze Gulgun, Md +905308705073 dr.gamzegulgun@yahoo.com
Contact: Dilek Yazicioglu, Md +905336957855 dilek.yazicioglu@hotmail.com

Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
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Study Chair: Murat Sayın, Assoc Prof Diskapi Yildirim Beyazit Education and Research Hospital
Publications:
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Responsible Party: Gamze GULGUN, Md, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02634255    
Other Study ID Numbers: Rocuronium onset
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gamze GULGUN, Diskapi Yildirim Beyazit Education and Research Hospital:
rocuronium
onset time
anxiety
Additional relevant MeSH terms:
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Appendicitis
Emergencies
Hernia, Inguinal
Disease Attributes
Pathologic Processes
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Fentanyl
Propofol
Rocuronium
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia