- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02988804
Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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four patients, to one of two groups to emerge from anesthesia with the ETT still in place (ETT group) or after it has been replaced by a LMA (LMA group).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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08019
- Anesthesia department, Hospital Clínic de Barcelona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: endotracheal tube
Procedure: Endotracheal tube Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
|
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:
|
Active Comparator: Laryngeal mask
Procedure: Laryngeal mask Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
changes from baseline systolic blood pressure in the first 60 minutes after extubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
noradrenaline levels
Time Frame: changes from baseline noradrenaline level at 30 minutes after awakening
|
Compare noradrenaline levels in both groups
|
changes from baseline noradrenaline level at 30 minutes after awakening
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paola Hurtado, MD, Senior Especialist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCB.2016.0781
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skull Base Neoplasms
-
M.D. Anderson Cancer CenterRecruiting
-
University of PittsburghRecruitingSkull Base Neoplasm | Cellular PathologyUnited States
-
Massachusetts General HospitalNational Cancer Institute (NCI)CompletedBrain Tumor | Head and Neck Tumor | Skull Base TumorUnited States
-
Baptist Health South FloridaNicklaus Children's Hospital f/k/a Miami Children's HospitalActive, not recruitingBrain Cancer | Brain Tumor | Skull Base TumorUnited States
-
Icahn School of Medicine at Mount SinaiNX Development CorpRecruitingNeoplasm | Skull Base NeoplasmUnited States
-
Assiut UniversityUnknownSkull Base NeoplasmsEgypt
-
Ohio State UniversityCompleted
-
Integra LifeSciences CorporationWithdrawn
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMalignant Central Nervous System Neoplasm | Malignant Skull Base NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingOsteoradionecrosis | Malignant Skull Base Neoplasm | Malignant Oral Cavity NeoplasmUnited States
Clinical Trials on endotracheal tube
-
Karaman Training and Research HospitalCompleted
-
Kyungpook National University HospitalCompletedCuff PressureKorea, Republic of
-
University Hospital, MontpellierCompletedCritically Ill | Intubation ComplicationFrance
-
Kyungpook National University HospitalCompletedEndotracheal Tube | Cuff PressureKorea, Republic of
-
Rambam Health Care CampusCompletedEndotracheal IntubationIsrael
-
Hallym University Kangnam Sacred Heart HospitalCompletedHeart ArrestKorea, Republic of
-
Antalya Training and Research HospitalNot yet recruitingObesity, Morbid | Intubation; Difficult or Failed
-
Groupe Hospitalier Pitie-SalpetriereAssociation pour la Recherche et la Formation en Anesthésie Analgésie RéanimationCompletedPostoperative PneumoniaFrance
-
Medical University of SilesiaCompletedPredictive Value of Tests | Intubation;DifficultPoland
-
C. R. BardCompletedRespiratory FailureUnited States