NCT03349658

Brief Summary

The purpose of the study is to compare the effects of spinal and general anesthesia on transcranial regional cerebral oxygen saturation in geriatric patients undergoing total hip arthroplasty.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

November 17, 2017

Last Update Submit

November 17, 2017

Conditions

Disorder of Hip Joint

Keywords

total hip arthroplastycerebral oxygen saturationgeneral anesthesiaspinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Change in transcranial regional cerebral oxygenation (rSO2)

    Assessed every 5 minutes during the procedure

    60 minutes

Secondary Outcomes (1)

  • Post anesthetic complications

    1 day

Study Arms (2)

general anesthesia

ACTIVE COMPARATOR

Patients in this group were randomized to receive general anesthesia.

Other: general anesthesia

spinal anesthesia

ACTIVE COMPARATOR

Patients in this group were randomized to receive spinal anesthesia.

Other: spinal anesthesia

Interventions

general anesthesiaOTHER

effect of general anesthesia on transcranial regional cerebral oxygen saturation

general anesthesia
spinal anesthesiaOTHER

effect of spinal anesthesia on transcranial regional cerebral oxygen saturation

spinal anesthesia

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patients who undergo elective total hip arthroplasty
  • American Society of Anesthesiologists class 1 to 3
  • Ability to consent

You may not qualify if:

  • Pulmonary disease
  • History of allergic reaction to local anaesthetics
  • Peripheral neuropathy
  • Neurologic disease
  • Coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Anesthesia, GeneralAnesthesia, Spinal

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Study Officials

  • Ozge Dagdelen, MD

    Antalya Training and Research Hospital

    STUDY DIRECTOR

  • Nilgun Kavrut Ozturk, MD

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

  • Ali Sait Kavakli, MD

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

  • Ülkü Arslan, MD

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11