Dexmedetomidine to Prevent Agitation After Free Flap Surgery

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904760
• Other study ID #: PKUSSIRB-2012006
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2013
• Last updated: November 5, 2014
• Start date: June 2013

Study information

• Verified date: November 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Agitation
• Delirium
• Psychomotor Agitation

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
China	School and Hospital of Stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	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	Yes
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.	on each of the 5 days postoperatively	No