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Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

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ClinicalTrials.gov Identifier: NCT01718470
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Collaborator:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
Ricard Valero, Fundació Clínic per la Recerca Biomèdica

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).

Condition or disease Intervention/treatment Phase
Hypertension on Emergence Procedure: Endotracheal tube Procedure: LMA Not Applicable

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the patient's assignment to one of two groups to emerge from anesthesia with the ETT still in place or after it had been replaced by an LMA.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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Proseal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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.
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Norepinephrine plasma concentration change [ Time Frame: 1 minute before anesthesia induction, 1 minute and 30 minutes after extubation, ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective craniotomy

Exclusion Criteria:

  • Difficult airway
  • Uncontrolled hypertension before surgery
  • gastroesophageal reflux

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by Ricard Valero, Fundació Clínic per la Recerca Biomèdica:
Systolic blood pressure
Heart rate
Laryngeal mask
Endotracheal tube
craniotomy