Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kreiskrankenhaus Dormagen
ClinicalTrials.gov Identifier:
NCT01782820
First received: January 31, 2013
Last updated: February 1, 2013
Last verified: January 2013
  Purpose

The aim of the present study is to compare the time course of a neuromuscular block in patients receiving dexamethasone 8 mg in order to reduce postoperative nausea or vomiting several hours before surgery with patients receiving the drug immediately before induction of anaesthesia and patients without a dexamethasone prophylaxis. The primary end point is the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9.


Condition
Neuromuscular Block, Dexamethasone
Neuromuscular Block, Recovery

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Kreiskrankenhaus Dormagen:

Primary Outcome Measures:
  • the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9. [ Time Frame: one hour ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
dexamethasone late
dexamethasone during induction of anesthesia
no dexamethasone
no dexamethasone during measurements
dexamethasone early
dexamethasone before induction of anesthesia

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients of a primary care clinic undergoing elective gynecologic abdominal surgery

Criteria

Inclusion Criteria:

  • patients aged 18 to 65 years,
  • American Society of Anesthesiologists Physical Status I or II,
  • 50-90 kg body weight,
  • undergoing elective laparoscopic gynaecological surgery in general anaesthesia necessitating intraoperative neuromuscular blockade.

Exclusion Criteria:

  • expected difficulties with endotracheal intubation (history of difficult intubation,
  • reduced opening of the mouth (< 2cm), and Mallampati Score of 4),
  • increased risk of pulmonary aspiration (gastrooesophageal reflux, full stomach, intestinal obstruction),
  • known allergies to the drugs tested,
  • pregnancy,
  • neuromuscular disorders,
  • intake of drugs affecting neuromuscular blockade, such as furosemide, magnesium or cephalosporins,
  • hepatic-or renal insufficiency.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01782820

Locations
Germany
Kreiskrankenhaus Dormagen
Dormagen, Germany, D-51375
Sponsors and Collaborators
Kreiskrankenhaus Dormagen
  More Information

No publications provided

Responsible Party: Kreiskrankenhaus Dormagen
ClinicalTrials.gov Identifier: NCT01782820     History of Changes
Other Study ID Numbers: dexarelax
Study First Received: January 31, 2013
Last Updated: February 1, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014