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

NCT ID: NCT01782820

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuromuscular Block, Dexamethasone Neuromuscular Block, Recovery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dexamethasone late

dexamethasone during induction of anesthesia

No interventions assigned to this group

no dexamethasone

no dexamethasone during measurements

No interventions assigned to this group

dexamethasone early

dexamethasone before induction of anesthesia

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kreiskrankenhaus Dormagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kreiskrankenhaus Dormagen

Dormagen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24136379 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

dexarelax

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dantrolene in Statin-induced Myopathy
NCT06966843 NOT_YET_RECRUITING PHASE2/PHASE3