NCT03399201

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 16, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

December 22, 2017

Last Update Submit

December 18, 2018

Conditions

AnesthesiaGeriatric Patients

Outcome Measures

Primary Outcomes (4)

  • The changes on forced vital capacity

    Forced vital capacity will be measured via spirometer

    At Preoperative, postoperative 2. hours, postoperative 24. hours

  • 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

  • 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

  • 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

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

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

Procedure: General anesthesiaDiagnostic Test: Spirometer

Neuraxial Anesthesia

ACTIVE COMPARATOR

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

Procedure: Neuraxial anesthesiaDiagnostic Test: Spirometer

Interventions

General anesthesiaPROCEDURE

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

General Anesthesia
Neuraxial anesthesiaPROCEDURE

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

Neuraxial Anesthesia
SpirometerDIAGNOSTIC_TEST

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

General AnesthesiaNeuraxial Anesthesia

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Hospital

Tokat Province, Merkez, 60100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Tuğba Karaman, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor,MD

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 16, 2018

Study Start

February 16, 2018

Primary Completion

December 2, 2018

Study Completion

December 2, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)