Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia
This study has been completed.
Sponsor:
Ricard Valero
Collaborator:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
Ricard Valero, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01718470
First received: October 18, 2012
Last updated: October 30, 2012
Last verified: October 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Hypertension on Emergence |
Procedure: Endotracheal tube Procedure: LMA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Proseal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients |
Resource links provided by NLM:
Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- Norepinephrine plasma concentration change [ Time Frame: 1 minute before anesthesia induction, 1 minute and 30 minutes after extubation, ] [ Designated as safety issue: Yes ]
| Enrollment: | 42 |
| Study Start Date: | July 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Endotracheal tube
At the end of surgery, emerge from anesthesia with the ETT still in place
|
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.
Other Name: Endotracheal tube
|
|
Active Comparator: Laryngeal mask
At the end of surgery,emerge from anesthesia after ETT had been replaced by an LMA.
|
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.
Other Name: Laryngeal mask
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Elective craniotomy
Exclusion Criteria:
- Difficult airway
- Uncontrolled hypertension before surgery
- gastroesophageal reflux
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718470
Locations
| Spain | |
| Anesthesia department, Hospital Clínic de Barcelona | |
| Barcelona, Spain, 08036 | |
Sponsors and Collaborators
Ricard Valero
Fundacion Clinic per a la Recerca Biomédica
Investigators
| Principal Investigator: | Perelló Laura, MD | Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona |
More Information
Publications:
| Responsible Party: | Ricard Valero, Ricard Valero M.D, Ph.D, Fundació Clínic per la Recerca Biomèdica |
| ClinicalTrials.gov Identifier: | NCT01718470 History of Changes |
| Other Study ID Numbers: | LMAvsETT |
| Study First Received: | October 18, 2012 |
| Last Updated: | October 30, 2012 |
| Health Authority: | Spain: Departament de Salut de la Generalitat de Catalunya |
Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
|
Systolic blood pressure Heart rate Laryngeal mask Endotracheal tube craniotomy |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013