Dexmedetomidine to Prevent Agitation After Free Flap Surgery
Primary Purpose
Agitation, Delirium
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Saline placebo
Sponsored by
About this trial
This is an interventional prevention trial for Agitation focused on measuring agitation, delirium, dexmedetomidine, head and neck surgery, microvascular free tissue transfer, flap
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
Sites / Locations
- School and Hospital of Stomatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dexmedetomidine
control
Arm 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.
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.
Outcomes
Primary Outcome Measures
Agitation in PACU
Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5.
Secondary Outcome Measures
Postoperative Delirium
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01904760
Brief Title
Dexmedetomidine to Prevent Agitation After Free Flap Surgery
Official Title
The Effect of Dexmedetomidine on Agitation and Delirium in Patients After Free Flap Reconstructive Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Delirium
Keywords
agitation, delirium, dexmedetomidine, head and neck surgery, microvascular free tissue transfer, flap
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine
Arm Type
Experimental
Arm 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.
Arm Title
control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Saline placebo
Intervention Description
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 Measure Information:
Title
Agitation in PACU
Description
Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5.
Time Frame
participants will be followed for the duration of PACU stay, an expected average of 12 hours
Secondary Outcome Measure Information:
Title
Postoperative Delirium
Description
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.
Time Frame
on each of the 5 days postoperatively
Other Pre-specified Outcome Measures:
Title
Patients' Vital Signs in PACU
Description
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.
Time Frame
participants will be followed for the duration of PACU stay, an expected average of 12 hours
Title
Use of Analgesics and Sedatives in PACU
Description
extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them.
Time Frame
participants will be followed for the duration of PACU stay, an expected average of 12 hours
Title
Pain Score in PACU
Description
Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU.
Time Frame
at 8 am the next day
Title
Sleep Quality in PACU
Description
Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day.
Time Frame
at 8am the next day
Title
Overall Feeling in PACU
Description
Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day.
Time Frame
at 8am the next day
Title
Sleep Quality Within 5 Days Postoperatively
Description
Participants are followed for 5 days after operation and their sleep quality are evaluated every afternoon on each of the 5 days.
Time Frame
on each of the 5 days postoperatively
Title
Pain Score Within 5 Days Postoperatively
Description
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.
Time Frame
on each of the 5 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
School and Hospital of Stomatology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100081
Country
China
12. IPD Sharing Statement
Learn more about this trial
Dexmedetomidine to Prevent Agitation After Free Flap Surgery
We'll reach out to this number within 24 hrs