Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Male

Ajou University School of Medicine

Status: Completed

Conditions: Gallbladder Diseases

Treatments: Drug: Sugammadex Injectable Product; Drug: Neostigmine Injectable Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03583021

AJIRB-MED-OBS-18-105

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 male patients who are reversed with sugammadex or neostigmine.

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: 42 patients

Sex: Male

Ages: 65 to 80 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: Double Blind

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42 participants in 2 patient groups, including a placebo group

sugammadex group

Experimental group

Description:

Sugammadex group receives the intravenous sugammadex of 3 mg/kg.

Treatment:

Drug: Sugammadex Injectable Product

neostigmine group

Placebo Comparator group

Description:

Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.

Treatment:

Drug: Neostigmine Injectable Product