Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

Hypertension on Emergence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718470
• Other study ID #: LMAvsETT
• Status: Completed
• Phase: N/A
• First received: October 18, 2012
• Last updated: October 30, 2012
• Start date: July 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2012
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical Trial 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).

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the patient's assignment to one of two groups to emerge from anesthesia with the ETT still in place or after it had been replaced by an LMA.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective craniotomy

Exclusion Criteria:

• Difficult airway

• Uncontrolled hypertension before surgery

• gastroesophageal reflux

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension on Emergence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Anesthesia department, Hospital Clínic de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Ricard Valero	Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Norepinephrine plasma concentration change		1 minute before anesthesia induction, 1 minute and 30 minutes after extubation,	Yes
Primary	systolic blood pressure change		1 minute before anesthesia induction, 5 minutes before extubation, and minute 1, 5, 10, 15, 30 and 60 after extubation	Yes
Secondary	heart rate change		1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation	Yes