Effect of Dexamethasone on the Action of Sugammadex

Attikon University Hospital

Status: Completed

Conditions: Neuromuscular Blockade

Treatments: Drug: sugammadex; Drug: Normal Saline; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02510157

711/19-3-15

Details and patient eligibility

About

This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients aged 18-70 years
• laparoscopic cholecystectomy
• operation < 3 hours

Exclusion criteria

• age <18 or >70 years old
• ASA physical status >3
• central nervous system diseases
• severe psychiatric disorders under treatment
• cognitive dysfunction
• known or suspected allergy to the administered drugs
• operations > 3 hours
• surgical intraoperative complications-open cholecystectomy
• severe renal or liver disease
• diabetes melitus
• immunosuppressed patients
• chronic immunosuppresant therapy (corticosteroids or other drugs)
• all contraindications to corticosteroids administration
• patiens on chronic use of opioids

Trial design

44 participants in 2 patient groups, including a placebo group

dexamethasone

Active Comparator group

Description:

Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.

Treatment:

Drug: Dexamethasone

Drug: sugammadex

normal saline

Placebo Comparator group

Description:

Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.

Treatment:

Drug: sugammadex

Drug: Normal Saline