Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery

Aneurysm Cerebral Clinical Trial

— DACA  

Official title:

Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355534
• Other study ID #: XJH-A-2017-10-10
• Status: Completed
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2022
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Cerebral
• Intracranial Aneurysm

Intervention

Drug:
• Intravenous dexmedetomidine
drug is intravenously infused to patients
• nasal dexmedetomidine
drug is nasally given to patients
• intravenous saline
saline is given to patients intravenously
• nasal saline
normal saline is given to patients nasally

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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 — View 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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of coughing		from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Secondary	Ricker's agitation-sedation score		from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Secondary	score of coughing	0=no coughing;1=intermittent coughing;2=continuous coughing	from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Secondary	time to response to verbal command		from end of infusing anesthetics to response to verbal command,averagely 20 minutes
Secondary	time to extubation		from end of infusing anesthetics to extubation,averagely 28 minutes
Secondary	blood pressure before and after extubation		from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Secondary	blood glucose before and after aneurysm embolism		immediately before inserting coil and after finishing inserting coil,an average of 1 hour
Secondary	blood lactate before and after aneurysm embolism		immediately before inserting coil and after finishing inserting coil,,an average of 1 hour
Secondary	Mini-mental state examination score		24 hours after surgery