Agitation, Delirium
Conditions
Keywords
agitation, delirium, dexmedetomidine, head and neck surgery, microvascular free tissue transfer, flap
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.
Interventions
DRUGDexmedetomidine
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.
DRUGSaline 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
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agitation in PACU | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Delirium | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Score in PACU | 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. |
| Sleep Quality in PACU | at 8am the next day | Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day. |
| Patients' Vital Signs in PACU | 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. |
| Sleep Quality Within 5 Days Postoperatively | 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. |
| Pain Score Within 5 Days Postoperatively | 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. |
| Overall Feeling in PACU | at 8am the next day | Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day. |
| Use of Analgesics and Sedatives in PACU | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| 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 | 40 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Control | Total |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 15 | 50.6 years STANDARD_DEVIATION 12.3 | 50.5 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment China | 39 participants | 40 participants | 79 participants |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 40 | 1 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Agitation in PACU
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexmedetomidine | Agitation in PACU | overall agitation in PACU | 15 participants |
| Dexmedetomidine | Agitation in PACU | agitation after PACU admission | 4 participants |
| Control | Agitation in PACU | overall agitation in PACU | 18 participants |
| Control | Agitation in PACU | agitation after PACU admission | 12 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.
Time frame: on each of the 5 days postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Postoperative Delirium | 2 participants |
| Control | Postoperative Delirium | 5 participants |
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.
Time frame: at 8am the next day
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.
Time frame: at 8 am the next day
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.
Time frame: 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.
Time frame: participants will be followed for the duration of PACU stay, an expected average of 12 hours
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.
Time frame: 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.
Time frame: on each of the 5 days postoperatively
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.
Time frame: participants will be followed for the duration of PACU stay, an expected average of 12 hours