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Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

Primary Purpose

Hypertension on Emergence

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Endotracheal tube

LMA

About this trial

This is an interventional prevention trial for Hypertension on Emergence focused on measuring Systolic blood pressure, Heart rate, Laryngeal mask, Endotracheal tube, craniotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Elective craniotomy

Exclusion Criteria:

Difficult airway
Uncontrolled hypertension before surgery
gastroesophageal reflux

Sites / Locations

Anesthesia department, Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Endotracheal tube

Laryngeal mask

Arm Description

At the end of surgery, emerge from anesthesia with the ETT still in place

At the end of surgery,emerge from anesthesia after ETT had been replaced by an LMA.

Outcomes

Primary Outcome Measures

systolic blood pressure change

Secondary Outcome Measures

heart rate change

Full Information

NCT ID

NCT01718470

First Posted

October 18, 2012

Last Updated

October 30, 2012

Sponsor

Ricard Valero

Collaborators

Fundacion Clinic per a la Recerca Biomédica

1. Study Identification

Unique Protocol Identification Number

NCT01718470

Brief Title

Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ricard Valero

Collaborators

Fundacion Clinic per a la Recerca Biomédica

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension on Emergence

Keywords

Systolic blood pressure, Heart rate, Laryngeal mask, Endotracheal tube, craniotomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endotracheal tube

Arm Type

Active Comparator

Arm Description

At the end of surgery, emerge from anesthesia with the ETT still in place

Arm Title

Laryngeal mask

Arm Type

Active Comparator

Arm Description

At the end of surgery,emerge from anesthesia after ETT had been replaced by an LMA.

Intervention Type

Procedure

Intervention Name(s)

Endotracheal tube

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

LMA

Other Intervention Name(s)

Laryngeal mask

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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 Pre-specified Outcome Measures:

Title

Norepinephrine plasma concentration change

Time Frame

1 minute before anesthesia induction, 1 minute and 30 minutes after extubation,

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Elective craniotomy Exclusion Criteria: Difficult airway Uncontrolled hypertension before surgery gastroesophageal reflux

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Perelló Laura, MD

Organizational Affiliation

Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anesthesia department, Hospital Clínic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

10475304

Citation

Bruder N, Stordeur JM, Ravussin P, Valli M, Dufour H, Bruguerolle B, Francois G. Metabolic and hemodynamic changes during recovery and tracheal extubation in neurosurgical patients: immediate versus delayed recovery. Anesth Analg. 1999 Sep;89(3):674-8. doi: 10.1097/00000539-199909000-00027.

Results Reference

result

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Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

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