Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery (DACA)

Zhihong LU

Status: Completed

Conditions: Aneurysm Cerebral

Treatments: Drug: nasal saline; Drug: nasal dexmedetomidine; Drug: Intravenous dexmedetomidine; Drug: intravenous saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03355534

XJH-A-2017-10-10

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

nasal dexmedetomidine

Experimental group

Description:

dexmedetomidine is given nasally, saline is given intravenously

Treatment:

Drug: intravenous saline

Drug: nasal dexmedetomidine

intravenous dexmedetomidine

Experimental group

Description:

saline is given nasally, dexmedetomidine is given intravenously

Treatment:

Drug: Intravenous dexmedetomidine

Drug: nasal saline

normal saline

Placebo Comparator group

Description:

saline is given nasally and intravenously

Treatment:

Drug: intravenous saline

Drug: nasal saline