Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02141412
• Date of registration: 15/05/2014
• Prospective Registration: No
• Primary sponsor: American University of Beirut Medical Center
• Public title: Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia
• Scientific title: Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study
• Date of first enrolment: September 2009
• Target sample size: 216
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02141412
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Lebanon

Contacts

• Name: Marie Aouad, MD
• Affiliation: American Univesity of Beirut Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18-80 year-old

- ASA class I, II, and III

- patients undergoing elective surgery under general anesthesia with an estimated time
of 1-3 h

Exclusion Criteria:

- duration of surgery less than 1h or more than 3 h

- allergy to dexmedetomidine

- vasoactive antidepressant or analgesics

- obesity (BMI>30)

- fever

- pregnancy



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anesthesia Emergence

Shivering

Anesthesia Recovery

Postoperative Recovery

Intervention(s)

Drug: dexmedetomidine 0.25 µg/kg IV

Drug: Placebo Comparator

Drug: dexmedetomidine 1 µg/kg IV

Drug: dexmedetomidine 0.5 µg/kg IV

Primary Outcome(s)

Postanaesthetic shivering incidence and score [Time Frame: change from baseline every 10 minutes up to 1 hour post-operatively]

Quality of emergence from anesthesia [Time Frame: Change from baseline every 5 minutes till extubation]

Secondary Outcome(s)

Patient's Temperature [Time Frame: every 10 minutes up to 1 hour post-operatively]

Pain scores [Time Frame: every 10 minutes up to 1 hour post-operatively]

Time to extubation, awakening and orientation [Time Frame: 1 hour post-operatively]

Nausea and vomiting [Time Frame: every 10 minutes up to 1 hour post-operatively]

Sedation scores [Time Frame: every 10 minutes up to 1 hour post-operatively]

Secondary ID(s)

ANES.MA.10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors