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Clinical Trials/NCT01722409
NCT01722409
Completed
Phase 4

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

China Medical University, China1 site in 1 country64 target enrollmentDecember 2012

Overview

Phase
Phase 4
Intervention
sevoflurane and 0.5 μg/kg dexmedetomidine
Conditions
Intracranial Aneurysms
Sponsor
China Medical University, China
Enrollment
64
Locations
1
Primary Endpoint
Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wen-fei Tan

Associate professor

China Medical University, China

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: sevoflurane and 0.5 μg/kg dexmedetomidine

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.

Intervention: sevoflurane and 1 μg/kg dexmedetomidine

Outcomes

Primary Outcomes

Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.

Time Frame: At the end of the operation and 24 hours later

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.

Study Sites (1)

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