Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- systolic blood pressure
Study Overview
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four patients, to one of two groups to emerge from anesthesia with the ETT still in place (ETT group) or after it has been replaced by a LMA (LMA group).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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- noradrenaline levels(changes from baseline noradrenaline level at 30 minutes after awakening)
Investigators
Ricard Valero
MD, PhD
Fundacion Clinic per a la Recerca Biomédica