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NCT Number: NCT03891745

Prone or Supine Extubation in Lomber Spinal Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medeniyet University

Istanbul, 34887, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Modified-Aldrete Scale

    Time frame: 1 hour

    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.

  2. Ricker's Agitation Scale

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

Emergence From Prone or Supine Extubation After Lomber Spinal Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2019
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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