Recruiting NCT07066605
The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group A (Dexmedetomidine Group), Group B (Control Group).
- Who it may be relevant to
- Registry conditions: Dexmedetomidine. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation in Critically Ill Patients"
Overview
This study aims to evaluate the effect of dexmedetomidine on the level of agitation during the weaning process from mechanical ventilation in critically ill patients.
Interventions
- Drug Group A (Dexmedetomidine Group)
patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr. - Drug Group B (Control Group)
patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl)
Primary outcome measures
- Effect of Dexmedetomidine on Agitation During Weaning from Mechanical Ventilation [Time frame: every half an hour for two hours]
Eligibility criteria
Inclusion criteria
- Adult ICU patients (≥18 years).
- On mechanical ventilation ≥24 hours.
- Clinically ready for weaning.
- Agitation score RASS ≥ +1 during spontaneous breathing trial.
- Intubation for at least 4 days: 2 weeks.
Exclusion criteria
- Known hypersensitivity to dexmedetomidine.
- Hemodynamic instability (HR < 50 bpm or MAP < 60 mmHg).
- Neurological impairment affecting level of consciousness.
- Pregnancy or lactation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Egypt · 1 center
- Sohag University Hospital — Sohag
Publications
- Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2. PMID 19188334
- Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, C PMID 30113379
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. PMID 17695343
Identifiers
NCT: NCT07066605 · Soh-Med-25-6---17MS