Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

Not Applicable

Completed

• Conditions: Hypertension on Emergence

• Registration Number: NCT01718470
• Lead Sponsor: Ricard Valero

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the patient's assignment to one of two groups to emerge from anesthesia with the ETT still in place or after it had been replaced by an LMA.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).

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Status Verified: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-30
• Last Update Submitted: 2012-10-30
• Study First Posted: 2012-10-31
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Elective craniotomy

Exclusion Criteria

• Difficult airway
• Uncontrolled hypertension before surgery
• gastroesophageal reflux

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
systolic blood pressure change	1 minute before anesthesia induction, 5 minutes before extubation, and minute 1, 5, 10, 15, 30 and 60 after extubation

Secondary Outcome Measures

Name	Time	Method
heart rate change	1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation

Trial Locations

Locations (1)

Anesthesia department, Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain