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NCT04563260 Clinical Trial

Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female

Gallbladder Diseases Clinical Trial

Official title:
Effect of Palonosetron on Effect-site Concentration of Remifentanil for Preventing Emergence Cough During General Anesthesia in Female Patients Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04563260
Other study ID # AJIRB-MED-THE-20-174
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2020
Est. completion date March 19, 2021

Study information
Verified date May 2021
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 female patients who receive the palonosetron or not.

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 45
Est. completion date March 19, 2021
Est. primary completion date March 19, 2021
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 85 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:
• Normal saline injection
Normal saline 2 mL, intravenous injection
• Palonosetron Injection [Aloxi]
Palonosetron 1.5 mL (0.075 mg) + Normal saline 0.5 mL, intravenous injection

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

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 end of surgery until the time of endotracheal extubation, about 20 minutes
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