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Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery

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ClinicalTrials.gov Identifier: NCT02988804
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ricard Valero, Fundacion Clinic per a la Recerca Biomédica

Brief Summary:
The endoscopic endonasal transsphenoidal surgery (EETS) is widely used. Although the incidence of complications is low, hypertensive episodes during surgery and awakening and cerebro spinal fluid (CSF) leakage have been described. The occurrence of coughing or vomiting during the early postoperative period must be avoid to protect the patient from CSF leakage and arterial hypertension. The emergency of anesthesia with laryngeal mask has a better haemodynamic profile and less incidence of cough in some surgical procedures and it could help minimizing the risks after EETS

Condition or disease Intervention/treatment Phase
Skull Base Neoplasms Device: endotracheal tube Device: Laryngeal mask Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: endotracheal tube

Procedure: Endotracheal tube

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

  • baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
  • end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
  • at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).
Device: endotracheal tube

In the Endotracheal group In the ETT group, the procedure will be exactly the same except that the ETT will not be exchanged and the patient will be directly extubated

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

  • baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
  • end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
  • at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).

Active Comparator: Laryngeal mask

Procedure: Laryngeal mask

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

  • baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
  • end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
  • at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).
Device: Laryngeal mask

In the LMA group, after aspirating pharyngeal secretions and with the patient still under general anesthesia, we will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

  • baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
  • end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
  • at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).




Primary Outcome Measures :
  1. systolic blood pressure [ Time Frame: changes from baseline systolic blood pressure in the first 60 minutes after extubation ]
    Changes in systolic blood pressure comparing two methods lma vs ett


Secondary Outcome Measures :
  1. noradrenaline levels [ Time Frame: changes from baseline noradrenaline level at 30 minutes after awakening ]
    Compare noradrenaline levels in both groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who undergo EETS in Hospital Clínic de Barcelona

Exclusion Criteria:

  • Re-interventions
  • Predicted difficult airway (severe acromegalia, mouth opening reduction) or Cormack-Lehane grade IV detected during laryngoscopy
  • Risk of bronchial aspiration (e.g., gastroesophageal reflux disease or lower cranial nerve palsy)
  • Uncontrolled arterial hypertension detected during preoperative assessment
  • Contraindication for early emergence based on anaesthetic or surgical criteria or as a result of complications developing during surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988804


Locations
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Spain
Anesthesia department, Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08019
Contact: Paola Hurtado    0034932275558    phurtado@clinic.ub.es   
Principal Investigator: Paola Hurtado, MD         
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
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Principal Investigator: Paola Hurtado, MD Senior Especialist

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Responsible Party: Ricard Valero, MD, PhD, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT02988804     History of Changes
Other Study ID Numbers: HCB.2016.0781
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ricard Valero, Fundacion Clinic per a la Recerca Biomédica:
endoscopic endonasal transsphenoidal surgery
laryngeal mask

Additional relevant MeSH terms:
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Skull Base Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs