A Better Choice for Patients Undergoing Endovascular Coil Embolization

Intracranial Aneurysms Clinical Trial

Official title:

Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722409
• Other study ID #: 20121009
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2012
• Last updated: June 23, 2015
• Start date: December 2012
• Est. completion date: February 2015

Study information

• Verified date: October 2013
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:18-65 years old ASA I or ASA II patients undergoing ECE treatment for intracranial aneurysms were included.

Exclusion Criteria:Patients were excluded based on the following parameters: older than 65 yrs, a history of mental illness, recent use of sedatives or analgesics and with sensation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Drug:
• sevoflurane and 0.5 µg/kg dexmedetomidine
After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 µg/kg over 10 minutes.
• sevoflurane and 1 µg/kg dexmedetomidine
After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 µg/kg over 10 minutes.

Locations

Country	Name	City	State
China	Wen-fei Tan	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.	The time from termination of the general anesthetic to the time that the patient's eyes opened. Anesthesiologists collected information on emergence agitation, postoperative nausea and vomiting for 24 hours after the surgery.	At the end of the operation and 24 hours later	Yes