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Prone or Supine Extubation in Lomber Spinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891745
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
mesure gul nihan ozden, Istanbul Medeniyet University

Brief 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.


Condition or disease
Lumbar Spinal Stenosis

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Emergence From Prone or Supine Extubation After Lomber Spinal Surgery
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Group/Cohort
prone group
prone extubation
supine group
supine extubation



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing lomber spinal surgery will be sected
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891745


Contacts
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Contact: MESURE GUL NIHAN G OZDEN, doctor +90 5323614400 nihanozdenn@gmail.com

Locations
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Turkey
Medeniyet University Recruiting
İ̇stanbul, Turkey, 34887
Contact: MESURE GUL NIHAN OZDEN, DOCTOR    +90 5323614400    nihanozdenn@gmail.com   
Sponsors and Collaborators
Istanbul Medeniyet University
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Responsible Party: mesure gul nihan ozden, Principal Investigator, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT03891745    
Other Study ID Numbers: 2018-0117
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases