NCT07066605

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

July 4, 2025

Last Update Submit

July 4, 2025

Conditions

Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Effect of Dexmedetomidine on Agitation During Weaning from Mechanical Ventilation

    Richmond Agitation-Sedation Scale

    every half an hour for two hours

Study Arms (2)

Group A (Dexmedetomidine Group)

ACTIVE COMPARATOR

patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr.

Drug: Group A (Dexmedetomidine Group)

Group B (Control Group)

PLACEBO COMPARATOR

patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl)

Drug: Group B (Control Group)

Interventions

Group A (Dexmedetomidine Group)DRUG

patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr.

Group A (Dexmedetomidine Group)
Group B (Control Group)DRUG

patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl)

Group B (Control Group)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known hypersensitivity to dexmedetomidine.
  • Hemodynamic instability (HR \< 50 bpm or MAP \< 60 mmHg).
  • Neurological impairment affecting level of consciousness.
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • 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: 19188334BACKGROUND

  • 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, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

    PMID: 30113379BACKGROUND

  • 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: 17695343BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Dalia A Hussein, Resident

CONTACT

01017666214najiza330@gmail.com

Al-haddad A Mousa, Professor

CONTACT

01019816967

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 15, 2025

Study Start

June 13, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations

EG(1)