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Clinical Trials/NCT01718470
NCT01718470
Completed
Not Applicable

Proseal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients

Ricard Valero1 site in 1 country42 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension on Emergence
Sponsor
Ricard Valero
Enrollment
42
Locations
1
Primary Endpoint
systolic blood pressure change
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Extubation and emergence from anesthesia lead to systemic and cerebral hemodynamic changes that can cause cerebral edema and hemorrhage. The hemodynamic profile on emergence is more favorable if a laryngeal mask airway (LMA) is inserted before neurosurgical patients emerge from anesthesia. We aimed to compare the impact of awakening neurosurgery patients after insertion of a ProSeal LMA to replace the endotracheal tube (ETT).

Detailed Description

At the end of surgery, the anesthesiologist opened a sealed envelope labeled with software-generated randomized numbers to learn the patient's assignment to one of two groups to emerge from anesthesia with the ETT still in place or after it had been replaced by an LMA. Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before awakening (ETT group) or before tube replacement (LMA group); and 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
March 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ricard Valero
Responsible Party
Sponsor Investigator
Principal Investigator

Ricard Valero

Ricard Valero M.D, Ph.D

Fundacion Clinic per a la Recerca Biomédica

Eligibility Criteria

Inclusion Criteria

  • Elective craniotomy

Exclusion Criteria

  • Difficult airway
  • Uncontrolled hypertension before surgery
  • gastroesophageal reflux

Outcomes

Primary Outcomes

systolic blood pressure change

Time Frame: 1 minute before anesthesia induction, 5 minutes before extubation, and minute 1, 5, 10, 15, 30 and 60 after extubation

Secondary Outcomes

  • heart rate change(1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation)

Study Sites (1)

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