Clinical trial NCT03355534: Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery
Official title: Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysm Cerebral
Keywords: dexmedetomidine
general anesthesia
cerebral aneurysm
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.


Eligibility criteria: Inclusion Criteria:

* patients undergoing cerebral aneurysm embolism under general anesthesia

Exclusion Criteria:

* patients with bradycardia or atrioventricular heart block
* patients with ASA(American Society of Anesthesiologists) status over 3
* patients with body mass index(BMI)≥30kg/m2
* patients with difficulty in communication
* patients with ruptured aneurysm
* patients suspected or proved to be pregnant

Primary outcomes:
measure: incidence of coughing
timeFrame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Secondary outcomes:
measure: Ricker's agitation-sedation score
timeFrame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
measure: score of coughing
timeFrame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
measure: time to response to verbal command
timeFrame: from end of infusing anesthetics to response to verbal command,averagely 20 minutes
measure: time to extubation
timeFrame: from end of infusing anesthetics to extubation,averagely 28 minutes
measure: blood pressure before and after extubation
timeFrame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
measure: blood glucose before and after aneurysm embolism
timeFrame: immediately before inserting coil and after finishing inserting coil,an average of 1 hour
measure: blood lactate before and after aneurysm embolism
timeFrame: immediately before inserting coil and after finishing inserting coil,,an average of 1 hour
measure: Mini-mental state examination score
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Lize Xiong
role: STUDY_CHAIR
References:
citation: Peng K, Wu S, Liu H, Ji F. Dexmedetomidine as an anesthetic adjuvant for intracranial procedures: meta-analysis of randomized controlled trials. J Clin Neurosci. 2014 Nov;21(11):1951-8. doi: 10.1016/j.jocn.2014.02.023. Epub 2014 Jun 25.
citation: Soliman RN, Hassan AR, Rashwan AM, Omar AM. Prospective, randomized controlled study to assess the role of dexmedetomidine in patients with supratentorial tumors undergoing craniotomy under general anesthesia. Middle East J Anaesthesiol. 2011 Feb;21(1):23-33.
citation: Elbakry AE, Ibrahim E. Propofol-dexmedetomidine versus propofol-remifentanil conscious sedation for awake craniotomy during epilepsy surgery. Minerva Anestesiol. 2017 Dec;83(12):1248-1254. doi: 10.23736/S0375-9393.17.11873-0. Epub 2017 Jun 14.
citation: Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
citation: Sun Y, Li Y, Sun Y, Wang X, Ye H, Yuan X. Dexmedetomidine Effect on Emergence Agitation and Delirium in Children Undergoing Laparoscopic Hernia Repair: a Preliminary Study. J Int Med Res. 2017 Jun;45(3):973-983. doi: 10.1177/0300060517699467. Epub 2017 Mar 21.