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.
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
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.
- Conditions
- Skull Base Neoplasms
- 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 group | Role | What they receive |
|---|---|---|
| endotracheal tube | Active comparator | 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). Receives: Device: endotracheal tube |
| Laryngeal mask | Active comparator | 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). Receives: Device: Laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted9 Dec 2016 (estimated)
- Study start20 Jan 2017
- Primary completion5 Nov 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull Base NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricard Valero, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Paola Hurtado, MD, Principal investigator, Senior Especialist
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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery
- ClinicalTrials.gov ID
- NCT02988804
- Acronym / sponsor ID
- HCB.2016.0781
- Conditions
- Skull Base Neoplasms
- Keywords
- endoscopic endonasal transsphenoidal surgery, laryngeal mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endotracheal tube | Active comparator | Device: endotracheal tubeProcedure: 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). |
| Laryngeal mask | Active comparator | Device: Laryngeal maskProcedure: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo EETS in Hospital Clínic de Barcelona
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal tubeIn 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). | Device | endotracheal tube |
| Laryngeal maskIn 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). | Device | Laryngeal mask |
Primary outcome
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
1 secondary outcome
noradrenaline levels
Time frame: changes from baseline noradrenaline level at 30 minutes after awakening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: Undecided
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Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Hurtado, MD principal investigator
Senior Especialist
1 site in 1 country: see every site and its status.
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.