Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Male

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

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

Study Overview

• Status: Completed
• Conditions: Gallbladder Diseases
• Intervention / Treatment: Drug: Sugammadex Injectable Product; Drug: Neostigmine Injectable Product

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Suwon, Seoul, Korea, Republic of
      • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
optimal Ce of remifentanil	Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia	from the ene of surgery until endotracheal extubation

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Ji Eun Kim, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: AJIRB-MED-OBS-18-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No