Effect of Dexamethasone on the Action of Sugammadex

Neuromuscular Blockade Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510157
• Other study ID #: 711/19-3-15
• Status: Completed
• Phase: N/A
• First received: May 16, 2015
• Last updated: October 2, 2016
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: University of Athens
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator)

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Dexamethasone
active comparator
• Normal Saline
placebo controlled intervention
• sugammadex
sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from end of surgery to extubation of patient	measurement of time after administration of the reversal agent (sugammadex) to achieve extubation of patient (up to 30 minutes)	minutes after administration of sugammadex (0 to 30 minutes)	No
Primary	Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex	measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes)	minutes after administration of sugammadex (0 to 30 minutes)	No
Secondary	Postoperative pain	Assessed by Numeric Rating Scale 0-10	1, 6, 12, 24 hours postoperatively	No
Secondary	Postoperative nausea and vomiting	Assessed by nausea/vomiting scale (11. Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth 2012; 108: 423-429)	1, 6, 12, 24 hours postoperatively	No