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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | on each of the 5 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Vital Signs in PACU | 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. | participants will be followed for the duration of PACU stay, an expected average of 12 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School and Hospital of Stomatology | Beijing | Beijing Municipality | 100081 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Agitation in PACU | Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5. | Posted | Number | participants | participants will be followed for the duration of PACU stay, an expected average of 12 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension in PACU | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xudong Yang | Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, China | 8610-82195287 | kqyangxudong@163.com |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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 |
|
| Use of Analgesics and Sedatives in PACU |
extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them. |
| participants will be followed for the duration of PACU stay, an expected average of 12 hours |
| Pain Score in PACU | Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU. | at 8 am the next day |
| Sleep Quality in PACU | Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day. | at 8am the next day |
| Overall Feeling in PACU | Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day. | at 8am the next day |
| Sleep Quality Within 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. | on each of the 5 days postoperatively |
| Pain Score Within 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. | on each of the 5 days postoperatively |
| BG001 |
| 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. 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Number | participants | on each of the 5 days postoperatively |
|
|
|
| Other Pre-specified | Patients' Vital Signs in PACU | 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. | Not Posted | participants will be followed for the duration of PACU stay, an expected average of 12 hours |
| Other Pre-specified | Use of Analgesics and Sedatives in PACU | extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them. | Not Posted | participants will be followed for the duration of PACU stay, an expected average of 12 hours |
| Other Pre-specified | Pain Score in PACU | Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU. | Not Posted | at 8 am the next day |
| Other Pre-specified | Sleep Quality in PACU | Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day. | Not Posted | at 8am the next day |
| Other Pre-specified | Overall Feeling in PACU | Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day. | Not Posted | at 8am the next day |
| Other Pre-specified | Sleep Quality Within 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. | Not Posted | on each of the 5 days postoperatively |
| Other Pre-specified | Pain Score Within 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. | Not Posted | on each of the 5 days postoperatively |
| 0 |
| 40 |
| 1 |
| 40 |
| EG001 | 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. 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 | 0 | 40 | 1 | 40 |
| bradycardia in PACU | Cardiac disorders | Systematic Assessment |
|
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| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003221 | Confusion |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |