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Phase 4 N=80 Randomized Quadruple-blind Prevention

Dexmedetomidine to Prevent Agitation After Free Flap Surgery

Agitation · Delirium

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Agitation in PACU — 15; 18; 4; 12 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Dexmedetomidine (Drug); Saline placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Peking University
Primary completion
Nov 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Agitation in PACU
15; 18; 4; 12
SECONDARY
Postoperative Delirium
2; 5

Summary

Reconstruction using microvascular free tissue flap has been an important management in patients with maxillofacial tumor. It is often characterised as long operation time, more traumatic and require restriction of patient's head movement postoperatively in order to prevent disruption of microvascular anastomosis. Agitation and delirium are common in patients with free flap surgery, which may lead to serious consequences such as self extubation, injury or even failure of the flap. Dexmedetomidine is a sedative and co-analgesic drug with high specificity for α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on preventing delirium has not been proved. The investigators hypothesized that the use of Dexmedetomidine would reduce emergence agitation and prevent delirium in patients after free flap surgery.

Eligibility Criteria

Inclusion Criteria

  • patients undergoing selected maxillofacial surgery with free flap reconstruction
  • American Society of Anesthesiologist(ASA) classification I and II

Exclusion Criteria

  • bradycardia (< 50 bpm)
  • severe heart block
  • low blood pressure(SBP<80mmHg)
  • Known allergy to alpha 2 agonists
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01904760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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