NCT02988804

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

Completed NA Last updated 29 May 2020

What this trial tests

NA trial testing endotracheal tube in Skull Base Neoplasms in 45 participants. Completed in 5 December 2019.

Timeline

20 January 2017

Primary endpoint
5 November 2019

5 December 2019

Quick facts

Lead sponsor	Fundacion Clinic per a la Recerca Biomédica
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	45
Start date	20 January 2017
Primary completion	5 November 2019
Estimated completion	5 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• endotracheal tube
• Laryngeal mask

Conditions studied

• Skull Base Neoplasms — all drugs for Skull Base Neoplasms →

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Who can join

18 and older, any sex, with Skull Base Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hemodynamic Response, Coughing and Incidence of Cerebrospinal Fluid Leakage on Awakening with an Endotracheal Tube or Laryngeal Mask Airway in Place after Transsphenoidal Pituitary Surgery: A Randomized Clinical Trial.
   Hurtado P, Tercero J, Garcia-Orellana M, Enseñat J, et al · · 2021 · cited 2× · PMID 34203476 · DOI 10.3390/jcm10132874
2. Hemodynamic response, coughing and the incidence of cerebrospinal fluid leakage on awakening with an endotracheal tube or laryngeal mask airway in place after transsphenoidal pituitary surgery: a randomized clinical trial
   Hurtado P, Tercero J, Garcia-Orellana M, Enseñat J, et al · · 2021 · DOI 10.21203/rs.3.rs-208707/v1