Dexmedetomidine to Prevent Agitation After Free Flap Surgery

NCT01904760 | Completed Phase 4 Results DMC

• 1 other identifier: PKUSSIRB-2012006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Agitation; Delirium

Keywords

agitation; delirium; dexmedetomidine; head and neck surgery; microvascular free tissue transfer; flap

Outcome Measures

Primary Outcomes (1)

• Agitation in PACU

  Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)\>=5.

  participants will be followed for the duration of PACU stay, an expected average of 12 hours

Secondary Outcomes (1)

• Postoperative Delirium

  on each of the 5 days postoperatively

Other Outcomes (7)

• Patients' Vital Signs in PACU

  participants will be followed for the duration of PACU stay, an expected average of 12 hours

• Use of Analgesics and Sedatives in PACU

  participants will be followed for the duration of PACU stay, an expected average of 12 hours

• Pain Score in PACU

  at 8 am the next day

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

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.

Drug: Dexmedetomidine

control

PLACEBO COMPARATOR

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.

Drug: Saline placebo

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex

dexmedetomidine

Saline placebo 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

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• bradycardia (\< 50 bpm)
• severe heart block
• low blood pressure(SBP\<80mmHg)
• Known allergy to alpha 2 agonists

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

School and Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Location

MeSH Terms

Conditions

Psychomotor Agitation; Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Confusion; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Xudong Yang
• Organization: Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, China

kqyangxudong@163.com

8610-82195287

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of the department of Anesthesiology

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 22, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Last Updated: November 13, 2014
• Results First Posted: November 13, 2014

Record last verified: 2014-11

Locations

CN (1)