Neuromuscular Block, DexamethasoneNCT01782820
Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium
An observational study of Neuromuscular Block, Dexamethasone and Neuromuscular Block, Recovery, run by Kreiskrankenhaus Dormagen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neuromuscular Block, Dexamethasone, Neuromuscular Block, Recovery
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients of a primary care clinic undergoing elective gynecologic abdominal surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone late | dexamethasone during induction of anesthesia | |
| no dexamethasone | no dexamethasone during measurements | |
| dexamethasone early | dexamethasone before induction of anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startDec 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Block, DexamethasoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kreiskrankenhaus Dormagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782820
- Sponsor's protocol ID
- dexarelax
- Status last verified
- Aug 2022
- First submitted
- 31 Jan 2013
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24136379
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium
- ClinicalTrials.gov ID
- NCT01782820
- Acronym / sponsor ID
- dexarelax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kreiskrankenhaus DormagenUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexamethasone late | – | –dexamethasone during induction of anesthesia |
| no dexamethasone | – | –no dexamethasone during measurements |
| dexamethasone early | – | –dexamethasone before induction of anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of a primary care clinic undergoing elective gynecologic abdominal surgery
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 24136379Soltesz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Block, Dexamethasone and Neuromuscular Block, Recovery, run by Kreiskrankenhaus Dormagen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.