Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery

Not Applicable

Completed

• Conditions: Aneurysm Cerebral
• Interventions: Drug: Intravenous dexmedetomidine; Drug: intravenous saline; Drug: nasal dexmedetomidine; Drug: nasal saline

• Registration Number: NCT03355534
• Lead Sponsor: Zhihong LU

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-19
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-28
• Study Start: 2018-01-05
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous dexmedetomidine	Intravenous dexmedetomidine	saline is given nasally, dexmedetomidine is given intravenously
intravenous dexmedetomidine	nasal saline	saline is given nasally, dexmedetomidine is given intravenously
normal saline	intravenous saline	saline is given nasally and intravenously
nasal dexmedetomidine	nasal dexmedetomidine	dexmedetomidine is given nasally, saline is given intravenously
nasal dexmedetomidine	intravenous saline	dexmedetomidine is given nasally, saline is given intravenously
normal saline	nasal saline	saline is given nasally and intravenously

Primary Outcome Measures

Name	Time	Method
incidence of coughing	from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China