Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female

Not Applicable

Completed

• Conditions: Gallbladder Diseases
• Interventions: Drug: Sugammadex Injectable Product; Drug: Neostigmine Injectable Product

• Registration Number: NCT04407078
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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

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 Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-29
• Status Verified: 2021-01
• Primary Completion: 2021-01-06
• Study Completion: 2021-01-06
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex group	Sugammadex Injectable Product	Sugammadex group receives the intravenous sugammadex of 2 mg/kg.
Neostigmine group	Neostigmine Injectable Product	Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.

Primary Outcome Measures

Name	Time	Method
optimal Ce of remifentanil	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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine; 🇰🇷 Suwon, Gyeonggido, Korea, Republic of