NCT01718470

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

5 months

First QC Date

October 18, 2012

Last Update Submit

October 30, 2012

Conditions

Hypertension on Emergence

Keywords

Systolic blood pressureHeart rateLaryngeal maskEndotracheal tubecraniotomy

Outcome Measures

Primary Outcomes (1)

  • systolic blood pressure change

    1 minute before anesthesia induction, 5 minutes before extubation, and minute 1, 5, 10, 15, 30 and 60 after extubation

Secondary Outcomes (1)

  • heart rate change

    1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation

Other Outcomes (1)

  • Norepinephrine plasma concentration change

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

Study Arms (2)

Endotracheal tube

ACTIVE COMPARATOR

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

Procedure: Endotracheal tube

Laryngeal mask

ACTIVE COMPARATOR

At the end of surgery,emerge from anesthesia after ETT had been replaced by an LMA.

Procedure: LMA

Interventions

Endotracheal tubePROCEDURE

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.

Endotracheal tube
LMAPROCEDURE

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.

Also known as: Laryngeal mask
Laryngeal mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective craniotomy

You may not qualify if:

  • Difficult airway
  • Uncontrolled hypertension before surgery
  • gastroesophageal reflux

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia department, Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 10475304RESULT

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Perelló Laura, MD

    Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ricard Valero M.D, Ph.D

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 31, 2012

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

ES(1)