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Anesthetics

LMA® is placed after anesthesia induction till the end of operation

Standard tracheal tube is inserted after anesthesia induction till the end of operation

LMA® is placed after anesthesia induction and removed after the operation

LMA®

Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation

Endotracheal tube

XiaoFeng Shen, MD

Airway management in anesthesia is critical to guarantee appropriate treatment of possible respiratory complications and successful operative practice. LMA® is an alternative to tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a superior manner in airway management in radical modified mastectomy on breast cancer than the tracheal tube, and the LMA® might produce less influence on patients' circulatory homeostasis, and easier to be placed before operation.

Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer

Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube for Airway Management in Modified Radical Mastectomy on Breast Cancer

Nanjing Medical University

XiRong Guo

Musculoskeletal Diseases

Skull Base Neoplasms

Skull Neoplasms

Bone Neoplasms

Bone Diseases

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).

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).

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).

endotracheal tube

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).

Laryngeal mask

Paola Hurtado, MD

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:

* 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.

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

Changes in systolic blood pressure comparing two methods lma vs ett

Compare noradrenaline levels in both groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer	NCT00638599	Breast Cancer	LMA® Endotracheal tu...	18 Years - 70 Years	Nanjing Medical University
Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery	NCT02988804	Skull Base Neop...	endotracheal tu... Laryngeal mask	18 Years -	Fundacion Clinic per a la Recerca Biomédica
Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery	NCT02988804	Skull Base Neop...	endotracheal tu... Laryngeal mask	18 Years -	Fundacion Clinic per a la Recerca Biomédica
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer	NCT00638599	Breast Cancer	LMA® Endotracheal tu...	18 Years - 70 Years	Nanjing Medical University

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