Prone or Supine Extubation in Lomber Spinal Surgery

Lumbar Spinal Stenosis Clinical Trial

Official title:

Emergence From Prone or Supine Extubation After Lomber Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891745
• Other study ID #: 2018-0117
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2021
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA I-II

• 18-65 years old

• need spinal surgery

Exclusion Criteria:

• difficult intubation

• BMI> 35kg / m2

• asthma and reactive airway problems

• cardiovascular disease

• obstructive sleep apnea

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Locations

Country	Name	City	State
Turkey	Medeniyet University	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified-Aldrete Scale	Modified-Aldrete Scale: It is used for postanesthesia recovery status. Its range from 0-10. When the values is between 9-10, the patient is ready to transport from postanesthetic care unit.	1 hour
Primary	Ricker's Agitation Scale	Ricker's Agitation Scale: This scale is used for sedation agitation status of the patients under sedatives in intensive care units or postanesthetic care units. Its range is between 1-7. The optimum wanted values are 3-4.	1 hour