Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01718470

Enrollment

Registered

2012-10-31

Start date

2011-07-31

Completion date

2012-03-31

Last updated

2012-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension on Emergence

Keywords

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

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the patient's assignment to one of two groups to emerge from anesthesia with the ETT still in place or after it had been replaced by an LMA.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

Interventions

PROCEDUREEndotracheal 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.

PROCEDURELMA

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Elective craniotomy

Exclusion criteria

* Difficult airway * Uncontrolled hypertension before surgery * gastroesophageal reflux

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
heart rate change	1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation

Other

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026