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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01782820
Recruitment Status : Completed
First Posted : February 4, 2013
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Neuromuscular Block, Dexamethasone Neuromuscular Block, Recovery

Study Design

Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Study Start Date : December 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
dexamethasone late
dexamethasone during induction of anesthesia
no dexamethasone
no dexamethasone during measurements
dexamethasone early
dexamethasone before induction of anesthesia


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782820


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kreiskrankenhaus Dormagen
ClinicalTrials.gov Identifier: NCT01782820     History of Changes
Other Study ID Numbers: dexarelax
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: January 2013

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