Trial Outcomes & Findings for Dexmedetomidine to Prevent Agitation After Free Flap Surgery (NCT NCT01904760)

Results Overview

Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)\>=5.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

participants will be followed for the duration of PACU stay, an expected average of 12 hours

Results posted on

2014-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	40	40
Overall Study COMPLETED	39	40
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Overall Study Protocol Violation	1	0

Baseline Characteristics

Dexmedetomidine to Prevent Agitation After Free Flap Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine n=39 Participants 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.	Control n=40 Participants 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	Total n=79 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 15.0 • n=5 Participants	50.6 years STANDARD_DEVIATION 12.3 • n=7 Participants	50.5 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment China	39 participants n=5 Participants	40 participants n=7 Participants	79 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=39 Participants 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.	Control n=40 Participants 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
Agitation in PACU overall agitation in PACU	15 participants	18 participants
Agitation in PACU agitation after PACU admission	4 participants	12 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=39 Participants 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.	Control n=40 Participants 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
Postoperative Delirium	2 participants	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at 8am the next day

Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at 8am the next day

Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexmedetomidine n=40 participants at risk 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.	Control n=40 participants at risk 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
Vascular disorders hypotension in PACU	0.00% 0/39	2.5% 1/40 • Number of events 1
Cardiac disorders bradycardia in PACU	2.5% 1/40 • Number of events 1	0.00% 0/40

Additional Information

Xudong Yang

Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, China

Phone: 8610-82195287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place