Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female

Ajou University School of Medicine

Status: Completed

Conditions: Gallbladder Diseases

Treatments: Drug: Normal saline injection; Drug: Palonosetron Injection [Aloxi]

Study type: Interventional

Funder types: Other

Identifiers

NCT04563260

AJIRB-MED-THE-20-174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Laparoscopic cholecystectomy under general anesthesia

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Control group receives the intravenous normal saline 2 mL.

Treatment:

Drug: Normal saline injection

Palonosetron group

Experimental group

Description:

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

Treatment:

Drug: Palonosetron Injection [Aloxi]