Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female

Not Applicable

Completed

• Conditions: Gallbladder Diseases
• Interventions: Drug: Normal saline injection; Drug: Palonosetron Injection [Aloxi]

• Registration Number: NCT04563260
• Lead Sponsor: 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 female patients who receive the palonosetron or not.

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 First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-24
• Study Start: 2020-10-07
• Primary Completion: 2021-03-19
• Study Completion: 2021-03-19
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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
Control group	Normal saline injection	Control group receives the intravenous normal saline 2 mL.
Palonosetron group	Palonosetron Injection [Aloxi]	Palonosetron group receives the intravenous palonosetron 1.5 mL (0.075 mg) + normal saline 0.5 mL.

Primary Outcome Measures

Name	Time	Method
optimal Ce of remifentanil	From the end of surgery until the time of endotracheal extubation, about 20 minutes	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, Korea, Republic of