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NCT Number: NCT01904760

Dexmedetomidine to Prevent Agitation After Free Flap Surgery

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

School and Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Precedex

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

The Effect of Dexmedetomidine on Agitation and Delirium in Patients After Free Flap Reconstructive Surgery

Important dates

Study start
2013
Primary completion
2013
First posted
Jul 22, 2013
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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