Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

NCT ID: NCT01718470

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-03-31

Brief Summary

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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

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the patient's assignment to one of two groups to emerge from anesthesia with the ETT still in place or after it had been replaced by an LMA.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

Conditions

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Hypertension on Emergence

Keywords

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Systolic blood pressure Heart rate Laryngeal mask Endotracheal tube craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Endotracheal tube

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

Group Type ACTIVE_COMPARATOR

Endotracheal tube

Intervention Type PROCEDURE

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.

Laryngeal mask

At the end of surgery,emerge from anesthesia after ETT had been replaced by an LMA.

Group Type ACTIVE_COMPARATOR

LMA

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Laryngeal mask

Eligibility Criteria

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Inclusion Criteria

* Elective craniotomy

Exclusion Criteria

* Difficult airway
* Uncontrolled hypertension before surgery
* gastroesophageal reflux
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role collaborator

Ricard Valero

OTHER

Sponsor Role lead

Responsible Party

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Ricard Valero

Ricard Valero M.D, Ph.D

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Perelló Laura, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona

Locations

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Anesthesia department, Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 10475304 (View on PubMed)

Other Identifiers

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LMAvsETT

Identifier Type: -

Identifier Source: org_study_id