Dexmedetomidine to Prevent Agitation After Free Flap Surgery

Peking University

Status and phase: Completed; Phase 4

Conditions: Delirium; Agitation

Treatments: Drug: Saline placebo; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01904760

PKUSSIRB-2012006

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

dexmedetomidine

Experimental group

Description:

Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.

Treatment:

Drug: Dexmedetomidine

control

Placebo Comparator group

Description:

Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.

Treatment:

Drug: Saline placebo