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

NCT02988804 | Completed

• 1 other identifier: HCB.2016.0781
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Skull Base Neoplasms

Keywords

endoscopic endonasal transsphenoidal surgery; laryngeal mask

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure

  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 Outcomes (1)

• noradrenaline levels

  changes from baseline noradrenaline level at 30 minutes after awakening

Study Arms (2)

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).

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).

Device: Laryngeal mask

Interventions

endotracheal tube DEVICE

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

Laryngeal mask DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo EETS in Hospital Clínic de Barcelona

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Anesthesia department, Hospital Clínic de Barcelona

Barcelona, 08019, Spain

Location

MeSH Terms

Conditions

Skull Base Neoplasms

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Paola Hurtado, MD

  Senior Especialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 9, 2016
• Study Start: January 20, 2017
• Primary Completion: November 5, 2019
• Study Completion: December 5, 2019
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

ES (1)