Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

October 30, 2012 updated by: Ricard Valero

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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the patient's assignment to one of two groups to emerge from anesthesia with the ETT still in place or after it had been replaced by an LMA.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

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Anesthesia department, Hospital Clínic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective craniotomy

Exclusion Criteria:

  • Difficult airway
  • Uncontrolled hypertension before surgery
  • gastroesophageal reflux

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Laryngeal mask

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Norepinephrine plasma concentration change
Time Frame: 1 minute before anesthesia induction, 1 minute and 30 minutes after extubation,
1 minute before anesthesia induction, 1 minute and 30 minutes after extubation,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ricard Valero

Collaborators

Fundacion Clinic per a la Recerca Biomédica

Investigators

  • Principal Investigator: Perelló Laura, MD, Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (ESTIMATE)

October 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 30, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMAvsETT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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