NCT03891745

Prone or Supine Extubation in Lomber Spinal Surgery

Completed Last updated 8 October 2021

What this trial tests

trial in Lumbar Spinal Stenosis in 60 participants. Completed in 1 October 2019.

Timeline

1 November 2018

Primary endpoint
1 October 2019

1 October 2019

Quick facts

Lead sponsor	Istanbul Medeniyet University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	1 November 2018
Primary completion	1 October 2019
Estimated completion	1 October 2019
Sites	1 location across Turkey (Türkiye)

Conditions studied

• Lumbar Spinal Stenosis — all drugs for Lumbar Spinal Stenosis →

Sponsor

Istanbul Medeniyet University

Who can join

Adults 18 to 65, any sex, with Lumbar Spinal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study was to investigate the emergence quality of patients extubated on prone or supine position after lumbar spinal surgery.

60 patients with ASA I-II who underwent lumbar spinal surgery between 18-65 years of age were included in the study. Patients with difficult intubation, BMI\> 35kg / m2, asthma and reactive airway problems, cardiovascular disease and obstructive sleep apnea will not be included in the study. Initial data will be recorded after standard monitorization. Induction is made by 2 mg / kg propofol, 1 mg / kg fentanyl and 0.5 mg / kg rocuronium will be added for muscle relaxation. Patients with adequate muscle relaxation will be intubated with appropriate endotracheal tube and mechanical ventilation will be initiated. Patients who are then given prone positions on the operating table will be supported with side gels. The head will be placed in the face gel in a neutral position. For intraoperative analgesia, remifentanil infusion at 0.2mcg / kg / min will be applied.

After laminectomy is completed and control of bleeding, 1 mg / kg Tramalol and 2 mg / kg Metaclopromide will be applied to all patients. At the end of the skin stitching, the inhalation agent will be closed and the fresh gas will be turned 6 lt 100% O2. Patients who want to be extubated in the prone position are left in this position while the other patients will be placed on the stretcher in a supine position for a short time. Patients will be decurarized be neostigmin with atropine. Extubation will be performed in both positions when spontanous ventilation begins at a tidal volume of 6ml / kg and a frequency of 12-20 / min. All the measures will be taken to ensure airway safety while the patient is extubated pron. The stretcher will be brought to the side of the operating table, investigator will be ready for reintubation and all the necessary persons will be with the patient. Aspiration frequency will be recorded for each patient. During recovery after extubation, the severity of cough will be evaluated as mild (only once), less (more than one but not continuous) and severe (continuously for 5 seconds). Aldrate scores of patient will be recorded and first 9-10 time is estimated from extubation time. Vomiting, nausea, respiratory insufficiency, inability to control the airway and obvious desaturation if seen are also recorded.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.