Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

This study has been completed.
Sponsor:
Collaborator:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
Ricard Valero, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01718470
First received: October 18, 2012
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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).


Condition Intervention
Hypertension on Emergence
Procedure: Endotracheal tube
Procedure: LMA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Proseal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • heart rate change [ Time Frame: 1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Norepinephrine plasma concentration change [ Time Frame: 1 minute before anesthesia induction, 1 minute and 30 minutes after extubation, ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endotracheal tube
At the end of surgery, emerge from anesthesia with the ETT still in place
Procedure: Endotracheal tube
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) and 1, 5, 10, 15, 30 and 60 min after extubation . The last blood pressure and heart rate measurements were taken in the postoperative recovery room.
Other Name: Endotracheal tube
Active Comparator: Laryngeal mask
At the end of surgery,emerge from anesthesia after ETT had been replaced by an LMA.
Procedure: 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 tube replacement (LMA group); and 1, 5, 10, 15, 30 and 60 min after LMA removal. The last blood pressure and heart rate measurements were taken in the postoperative recovery room.
Other Name: Laryngeal mask

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective craniotomy

Exclusion Criteria:

  • Difficult airway
  • Uncontrolled hypertension before surgery
  • gastroesophageal reflux
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718470

Locations
Spain
Anesthesia department, Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Ricard Valero
Fundacion Clinic per a la Recerca Biomédica
Investigators
Principal Investigator: Perelló Laura, MD Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona
  More Information

Publications:
Responsible Party: Ricard Valero, Ricard Valero M.D, Ph.D, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01718470     History of Changes
Other Study ID Numbers: LMAvsETT
Study First Received: October 18, 2012
Last Updated: October 30, 2012
Health Authority: Spain: Departament de Salut de la Generalitat de Catalunya

Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
Systolic blood pressure
Heart rate
Laryngeal mask
Endotracheal tube
craniotomy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014