Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female

NCT ID: NCT04563260

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2021-03-19

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.

Conditions

Gallbladder Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control group

Control group receives the intravenous normal saline 2 mL.

Group Type: PLACEBO_COMPARATOR

Normal saline injection

Intervention Type: DRUG

Normal saline 2 mL, intravenous injection

Palonosetron group

Palonosetron group receives the intravenous palonosetron 1.5 mL (0.075 mg) + normal saline 0.5 mL.

Group Type: EXPERIMENTAL

Palonosetron Injection [Aloxi]

Intervention Type: DRUG

Palonosetron 1.5 mL (0.075 mg) + Normal saline 0.5 mL, intravenous injection

Interventions

Normal saline injection

Normal saline 2 mL, intravenous injection

Intervention Type: DRUG

Palonosetron Injection [Aloxi]

Palonosetron 1.5 mL (0.075 mg) + Normal saline 0.5 mL, intravenous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ji Eun Kim

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Suwon, , South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-THE-20-174

Identifier Type: -

Identifier Source: org_study_id