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Dexmedetomidine to Prevent Agitation After Free Flap Surgery

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ClinicalTrials.gov Identifier: NCT01904760
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Yang Xudong, Peking University

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.


Condition or disease Intervention/treatment Phase
Agitation Delirium Drug: Dexmedetomidine Drug: Saline placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Dexmedetomidine on Agitation and Delirium in Patients After Free Flap Reconstructive Surgery
Study Start Date : June 2013
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: dexmedetomidine
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
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.
Other Name: Precedex

Placebo Comparator: control
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
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




Primary Outcome Measures :
  1. Agitation in PACU [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 12 hours ]
    Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5.


Secondary Outcome Measures :
  1. Postoperative Delirium [ Time Frame: on each of the 5 days postoperatively ]
    Patients are sent back to wards the next morning after operation and followed up on each of the 5 days postoperatively. Delirium will be confirmed based on CAM-ICU method.


Other Outcome Measures:
  1. Patients' Vital Signs in PACU [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 12 hours ]
    Patient's vital signs including heart rate, blood pressure, pulse oxygen saturation and respiratory rate are monitored continuously in PACU and recorded on 1,2,4,6,12 hour after PACU admission.

  2. Use of Analgesics and Sedatives in PACU [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 12 hours ]
    extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them.

  3. Pain Score in PACU [ Time Frame: at 8 am the next day ]
    Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU.

  4. Sleep Quality in PACU [ Time Frame: at 8am the next day ]
    Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day.

  5. Overall Feeling in PACU [ Time Frame: at 8am the next day ]
    Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day.

  6. Sleep Quality Within 5 Days Postoperatively [ Time Frame: on each of the 5 days postoperatively ]
    Participants are followed for 5 days after operation and their sleep quality are evaluated every afternoon on each of the 5 days.

  7. Pain Score Within 5 Days Postoperatively [ Time Frame: on each of the 5 days postoperatively ]
    Participants are followed for 5 days after operation and their pain score are evaluated by VAS method every afternoon on each of the 5 days. Patients' pain score on maxillofacial region and flap donation region are evaluated respectively.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904760


Locations
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China, Beijing
School and Hospital of Stomatology
Beijing, Beijing, China, 100081
Sponsors and Collaborators
Peking University

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Responsible Party: Yang Xudong, vice director of the department of Anesthesiology, Peking University
ClinicalTrials.gov Identifier: NCT01904760    
Other Study ID Numbers: PKUSSIRB-2012006
First Posted: July 22, 2013    Key Record Dates
Results First Posted: November 13, 2014
Last Update Posted: November 13, 2014
Last Verified: November 2014
Keywords provided by Yang Xudong, Peking University:
agitation
delirium
dexmedetomidine
head and neck surgery
microvascular free tissue transfer
flap
Additional relevant MeSH terms:
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Delirium
Psychomotor Agitation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Psychomotor Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action