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

Primary Purpose

Skull Base Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
endotracheal tube
Laryngeal mask
Sponsored by
Fundacion Clinic per a la Recerca Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skull Base Neoplasms focused on measuring endoscopic endonasal transsphenoidal surgery, laryngeal mask

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anesthesia department, Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

endotracheal tube

Laryngeal mask

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

systolic blood pressure
Changes in systolic blood pressure comparing two methods lma vs ett

Secondary Outcome Measures

noradrenaline levels
Compare noradrenaline levels in both groups

Full Information

First Posted
December 1, 2016
Last Updated
May 27, 2020
Sponsor
Fundacion Clinic per a la Recerca Biomédica
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1. Study Identification

Unique Protocol Identification Number
NCT02988804
Brief Title
Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery
Official Title
Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Randomization At the end of surgery, the anesthesiologist will open a sealed envelope labeled with software-generated randomized numbers to assign the patients, who will be allocated in a 1:1 ratio from nonstratified blocks of four patients, to one of two groups to emerge from anesthesia with the ETT still in place (ETT group) or after it has been replaced by a LMA (LMA group). Study procedure In the LMA group, after aspirating pharyngeal secretions and with the patient still under general anesthesia, the investigators will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique. Specifically, the LMA will be inserted after first advancing a suction catheter along the drain tube 8-10 cm beyond the distal end; the mask will be then inserted using a digital technique behind the orotracheal tube, allowing the suction catheter to enter the esophagus first and guiding the tip of the cuff. A number 4 or 5 mask will be chosen for patients weighing 50-70 kg or 70-100 kg, respectively. The cuff will be inflated to a pressure of 60 cmH2O measured with a manometer. Then the orotracheal tube balloon will be deflated and the tube removed. Ventilation then will be continued with the same parameters as had been used earlier. Administration of neuromuscular relaxants will be then stopped so the patient could emerge from anesthesia. Once the patient recover 2/4 responses of the TOF, neostigmine (0.03 mg/Kg) and atropine (0.01mg/kg) will be given to reverse the neuromuscular blockade and Target-controlled infusion of anesthetics will be stopped. Lidocaine will not be administrated. Gentle manual ventilator assistance will be then provided until the patient resume spontaneous breathing and respond to simple commands; the LMA or the ETT, depending on the group, will be then removed. The investigators will administer prophylaxis of nausea in the postoperative period with ondansetron 4 mg/8h/iv. 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 when the patient will fulfill the same criteria. Parameters Patient variables (age, weight, height, sex) and relevant aspects of past medical history, such as: controlled hypertension tobacco addiction respiratory disease will be also registered, including sleep apnea and any chronic respiratory disease (chronic bronquitis, emphysema, chronic pulmonary obstructive disease). cough test Diagnosis, type of surgery, the placement of lumbar drainage. 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). The last blood pressure and HR measurements will be taken in the postoperative recovery room. Respiratory variables (including end-tidal carbon dioxide concentration) will be controlled during MV. Neurosurgeon will rate the amount of blood in the surgical field (1: no blood; 2: small bleeding that does not interfere with surgery; 3: bleeding that interferes with surgery but surgery is possible; 4: bleeding that impedes normal development of surgery). Any coughing episode during the first 5 minutes of awakening. Considering light coughing (1 cough) and strong coughing (access of cough). Preoperative xylometazoline administration. Intraoperative hypertension and antihypertensive agent administered. Endotracheal tube size and laryngeal mask size. Difficulties in LMA ventilation. Postoperative nausea or vomiting CSF leakage during the admission and in the first month. Postoperative bleeding. The objective of the investigators study is evaluate the incidence of coughing and hypertension during awakening in patients after EETS comparing the effect of laryngeal mask vs orotracheal tube.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skull Base Neoplasms
Keywords
endoscopic endonasal transsphenoidal surgery, laryngeal mask

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endotracheal tube
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Laryngeal mask
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
endotracheal tube
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Laryngeal mask
Intervention Description
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 Measure Information:
Title
systolic blood pressure
Description
Changes in systolic blood pressure comparing two methods lma vs ett
Time Frame
changes from baseline systolic blood pressure in the first 60 minutes after extubation
Secondary Outcome Measure Information:
Title
noradrenaline levels
Description
Compare noradrenaline levels in both groups
Time Frame
changes from baseline noradrenaline level at 30 minutes after awakening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Hurtado, MD
Organizational Affiliation
Senior Especialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesia department, Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08019
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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