An interventional study of endotracheal tube and Laryngeal mask in Skull Base Neoplasms, sponsored by Fundacion Clinic per a la Recerca Biomédica. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-29.
Sponsored by Fundacion Clinic per a la Recerca Biomédica · Not applicable, Interventional, and Prevention
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
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four patients, to one of two groups to emerge from anesthesia with the ETT still in place (ETT group) or after it has been replaced by a LMA (LMA group).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:
Diagnosis, type of surgery, the placement of lumbar drainage.
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
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.
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.
Fundacion Clinic per a la Recerca Biomédica is the lead sponsor of 63 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 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).
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).
systolic blood pressure
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
noradrenaline levels
Compare noradrenaline levels in both groups
Time frame: changes from baseline noradrenaline level at 30 minutes after awakening
Plan to share: Undecided
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Skull Base Neoplasms
Fundacion Clinic per a la Recerca Biomédica