AzTrials
AzTrials

Skull Base NeoplasmsNCT02988804

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

A study testing endotracheal tube and Laryngeal mask in people with Skull Base Neoplasms, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skull Base Neoplasms
What is being tested?
endotracheal tube and Laryngeal mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSpain
Study dates
20 Jan 2017to 5 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who undergo EETS in Hospital Clínic de Barcelona

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Anesthesia department, Hospital Clínic de Barcelona

    Barcelona, 08019

Other trials in Spain

About this study

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

Read the 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.

Being tested
endotracheal tube, Laryngeal mask
Keywords
endoscopic endonasal transsphenoidal surgery, laryngeal mask
Medical subject headings
Skull Base Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endotracheal tubeDevice

    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).
  • Laryngeal maskDevice

    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).
Study groups in NCT02988804
Study groupRoleWhat they receive
endotracheal tubeActive comparatorProcedure: 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).
Receives: Device: endotracheal tube
Laryngeal maskActive comparatorProcedure: 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).
Receives: Device: Laryngeal mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. systolic blood pressure

    Changes in systolic blood pressure comparing two methods lma vs ett

    Measured: changes from baseline systolic blood pressure in the first 60 minutes after extubation

Secondary outcomes (1)
  1. noradrenaline levels

    Compare noradrenaline levels in both groups

    Measured: changes from baseline noradrenaline level at 30 minutes after awakening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2016 (estimated)
  2. Study start20 Jan 2017
  3. Primary completion5 Nov 2019
  4. Study completion5 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02988804
Sponsor's protocol ID
HCB.2016.0781
Status last verified
May 2020
First submitted
1 Dec 2016
Last updated
29 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing endotracheal tube and Laryngeal mask in people with Skull Base Neoplasms, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

systolic blood pressure (time frame: changes from baseline systolic blood pressure in the first 60 minutes after extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in