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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03399201
Other study ID # Spiro
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 16, 2018
Est. completion date December 2, 2018

Study information

Verified date December 2018
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2, 2018
Est. primary completion date December 2, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years to 95 Years
Eligibility Inclusion Criteria:

- 65 years of age

- Undergoing non-abdominal surgery under anesthesia in supine position

Exclusion Criteria:

- Pulmonary disease

- Hematological disease

- Undergoing Abdominal surgery

- Non-supine position during surgery

- Nicotine Abuse

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
General anesthesia
induction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane)
Neuraxial anesthesia
Spinal anesthesia will be applied via the local anesthetic ( Bupivacaine).
Diagnostic Test:
Spirometer
Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)

Locations

Country Name City State
Turkey Gaziosmanpasa University Hospital Tokat Merkez

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The changes on forced vital capacity Forced vital capacity will be measured via spirometer At Preoperative, postoperative 2. hours, postoperative 24. hours
Primary The changes on forced expiratory volume in 1 s Forced expiratory volume in 1 s will be measured via spirometer At Preoperative, postoperative 2. hours, postoperative 24. hours
Primary The changes on mid-expiratory flow (MEF 25-75) mid-expiratory flow (MEF 25-75) will be measured via spirometer At Preoperative, postoperative 2. hours, postoperative 24. hours
Primary The changes on peak expiratory flow (PEF) Peak expiratory flow (PEF) will be measured by the spirometer At Preoperative, postoperative 2. hours, postoperative 24. hours
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