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NCT03583021 Clinical Trial

Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Male

Gallbladder Diseases Clinical Trial

Official title:
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03583021
Other study ID # AJIRB-MED-OBS-18-105
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2018
Est. completion date December 31, 2018

Study information
Verified date May 2020
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 male patients who are reversed with sugammadex or neostigmine.

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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date December 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender Male
Age group 65 Years to 80 Years
Eligibility Inclusion Criteria:

- Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sugammadex Injectable Product
Sugammadex of 3 mg/kg is injected.
• Neostigmine Injectable Product
Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine Suwon Seoul

Sponsors (1)
Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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