Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium
1 other identifier
observational
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 31, 2013
CompletedFirst Posted
Study publicly available on registry
February 4, 2013
CompletedAugust 17, 2022
August 1, 2022
1.1 years
January 31, 2013
August 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9.
one hour
Study Arms (3)
dexamethasone late
dexamethasone during induction of anesthesia
no dexamethasone
no dexamethasone during measurements
dexamethasone early
dexamethasone before induction of anesthesia
Eligibility Criteria
patients of a primary care clinic undergoing elective gynecologic abdominal surgery
You may qualify if:
- patients aged 18 to 65 years,
- American Society of Anesthesiologists Physical Status I or II,
- kg body weight,
- undergoing elective laparoscopic gynaecological surgery in general anaesthesia necessitating intraoperative neuromuscular blockade.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kreiskrankenhaus Dormagen
Dormagen, D-51375, Germany
Related Publications (1)
Soltesz S, Fraisl P, Noe KG, Hinkelbein J, Mellinghoff H, Mencke T. Dexamethasone decreases the duration of rocuronium-induced neuromuscular block: a randomised controlled study. Eur J Anaesthesiol. 2014 Aug;31(8):417-22. doi: 10.1097/EJA.0b013e328365c9ee.
PMID: 24136379DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 4, 2013
Study Start
December 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
August 17, 2022
Record last verified: 2022-08