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Completed

NCT Number: NCT02510157

Effect of Dexamethasone on the Action of Sugammadex

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, 12462, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

active comparator

normal saline

Drug

placebo controlled intervention

Other names: N/S 0.9%

Sugammadex

Drug

sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery

Primary outcomes

  1. Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex

    Time frame: minutes after administration of sugammadex (0 to 30 minutes)

    measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes)

Secondary outcomes

  1. Postoperative pain

    Time frame: 1, 6, 12, 24 hours postoperatively

    Assessed by Numeric Rating Scale 0-10

  2. Postoperative nausea and vomiting

    Time frame: 1, 6, 12, 24 hours postoperatively

    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)

Other outcomes

  1. Time from end of surgery to extubation of patient

    Time frame: minutes after administration of sugammadex (0 to 30 minutes)

    measurement of time after administration of the reversal agent (sugammadex) to achieve extubation of patient (up to 30 minutes)

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2015
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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