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CompletedNCT03399201Updated Dec 19, 2018

The Effect of Anesthesia Type on Pulmonary Function

An interventional study of General anesthesia and Neuraxial anesthesia in Anesthesia and Geriatric Patients, sponsored by Tokat Gaziosmanpasa University. Completed at 1 site in Turkey. Open to participants aged 65 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by Tokat Gaziosmanpasa University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years to 95 Years
Sex
All
01

Study summary

The role of neuraxial anesthesia in preventing respiratory complications is a controversial in elderly patients. The aim of the study was to evaluate the benefits of neuraxial anesthesia on pulmonary function during post-operative term in geriatric patients undergoing to elective non-abdominal surgery.

Read the detailed description

Sixty elder patients will be randomly assigned to General anesthesia or Neuraxial anesthesia groups. Spirometry, will be performed at pre-operative and post-operative terms. Pulmonary function tests will be evaluated.

02

Conditions studied

  • Anesthesia
  • Geriatric Patients
03

Who can participate

Ages eligible
65 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 65 years of age
  • Undergoing non-abdominal surgery under anesthesia in supine position

Exclusion criteria

Exclusion Criteria:

  • Pulmonary disease
  • Hematological disease
  • Undergoing Abdominal surgery
  • Non-supine position during surgery
  • Nicotine Abuse
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    General Anesthesia

    Standard General Anesthesia will be applied.The change of the pulmonary functions will be evaluated via spirometer.

    Procedure: General anesthesia · Diagnostic Test: Spirometer

  • Active comparator
    Neuraxial Anesthesia

    Neuraxial anesthesia will be applied. The change of the pulmonary functions will be evaluated via spirometer.

    Procedure: Neuraxial anesthesia · Diagnostic Test: Spirometer

Interventions

  • ProcedureGeneral anesthesia

    induction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane)

  • ProcedureNeuraxial anesthesia

    Spinal anesthesia will be applied via the local anesthetic ( Bupivacaine).

  • Diagnostic testSpirometer

    Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)

05

What researchers measure

Primary outcomes

  1. The changes on forced vital capacity

    Forced vital capacity will be measured via spirometer

    Time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours

  2. The changes on forced expiratory volume in 1 s

    Forced expiratory volume in 1 s will be measured via spirometer

    Time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours

  3. The changes on mid-expiratory flow (MEF 25-75)

    mid-expiratory flow (MEF 25-75) will be measured via spirometer

    Time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours

  4. The changes on peak expiratory flow (PEF)

    Peak expiratory flow (PEF) will be measured by the spirometer

    Time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours

06

Study locations

1 site
  • Gaziosmanpasa University Hospital
    Tokat, Merkez 60100, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03399201
Lead sponsor
Tokat Gaziosmanpasa University
Responsible party
Tuğba Karaman (Associate Professor,MD, Tokat Gaziosmanpasa University) — Principal investigator
First posted
Jan 16, 2018
Start date
Feb 16, 2018
Primary completion
Dec 2, 2018
Completion
Dec 2, 2018
Last update
Dec 19, 2018

Study contacts

Tuğba Karaman, MD
principal investigator · Associate Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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