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Sugammadex on Remifentanil Ce for Preventing Emergence Cough

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ClinicalTrials.gov Identifier: NCT03583021
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Eun Kim, Ajou University School of Medicine

Brief Summary:
The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in patients who are reversed with sugammadex or neostigmine.

Condition or disease Intervention/treatment Phase
Gallbladder Diseases Drug: Sugammadex Injectable Product Drug: Neostigmine Injectable Product Not Applicable

Detailed Description:
Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sugammadex group
Sugammadex group receives the intravenous sugammadex of 3 mg/kg.
Drug: Sugammadex Injectable Product
Sugammadex of 3 mg/kg is injected.

Placebo Comparator: neostigmine group
Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.
Drug: Neostigmine Injectable Product
Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.




Primary Outcome Measures :
  1. optimal Ce of remifentanil [ Time Frame: from the ene of surgery until endotracheal extubation ]
    Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia



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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

  • BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension

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): NCT03583021


Contacts
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Contact: Ji Eun Kim 82-31-219-5575 beye98@aumc.a.ckr

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine Recruiting
Suwon, Seoul, Korea, Republic of
Contact: Ji Eun Kim    82-31-219-5575      
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: Ji Eun Kim Ajou University School of Medicine

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Responsible Party: Ji Eun Kim, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03583021     History of Changes
Other Study ID Numbers: AJIRB-MED-OBS-18-105
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents