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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02510157
Other study ID # 711/19-3-15
Secondary ID
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


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
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