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

NCT02988804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-05-29

No results posted yet for this study

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

Interventions

DEVICE

endotracheal tube

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).

DEVICE

Laryngeal mask

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).

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Principal Investigators

  • Paola Hurtado, MD · Senior Especialist

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-20
Primary Completion
2019-11-05
Completion
2019-12-05

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02988804 on ClinicalTrials.gov