Disorder of Hip JointNCT03349658
Cerebral Oximetry and Anesthetic Technique
A study testing general anesthesia and spinal anesthesia in people with Disorder of Hip Joint, run by Antalya Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Disorder of Hip Joint
- What is being tested?
- general anesthesia and spinal anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients who undergo elective total hip arthroplasty
- American Society of Anesthesiologists class 1 to 3
- Ability to consent
Who cannot join
- Pulmonary disease
- History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Neurologic disease
- Coagulation disorders
About this study
Official title: Evaluation of the Effects of Spinal Versus General Anesthesia on Transcranial Cerebral Oxygen Saturation in Geriatric Patients Undergoing Total Hip Arthroplasty
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.
Read the detailed description
Geriatric patients who received anesthesia undergoing total hip arthroplasty were randomized by means of a computer-generated randomization order into two groups; general anesthesia group (Group 1) and spinal anesthesia group (Group 2). Before and after induction of the general or spinal anesthesia, patients were monitorized with near infrared spectroscopy for regional cerebral oxygen saturation. Findings were compared statistically.
- Conditions
- Disorder of Hip Joint
- Being tested
- general anesthesia, spinal anesthesia
- Keywords
- total hip arthroplasty, cerebral oxygen saturation, general anesthesia, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaOther
effect of general anesthesia on transcranial regional cerebral oxygen saturation
spinal anesthesiaOther
effect of spinal anesthesia on transcranial regional cerebral oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Active comparator | Patients in this group were randomized to receive general anesthesia. Receives: Other: general anesthesia |
| spinal anesthesia | Active comparator | Patients in this group were randomized to receive spinal anesthesia. Receives: Other: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transcranial regional cerebral oxygenation (rSO2)
Assessed every 5 minutes during the procedure
Measured: 60 minutes
Secondary outcomes (1)
Post anesthetic complications
During stay at the post anesthetic care unit. Any new neurological symptoms etc
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study startJan 2017
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Hip JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ozge Dagdelen, MD, Study director, Antalya Training and Research HospitalNilgun Kavrut Ozturk, MD, Principal investigator, Antalya Training and Research HospitalAli Sait Kavakli, MD, Principal investigator, Antalya Training and Research HospitalÜlkü Arslan, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349658
- Sponsor's protocol ID
- AntalyaTRH 17
- Status last verified
- Nov 2017
- First submitted
- 17 Nov 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Spinal Versus General Anesthesia on Transcranial Cerebral Oxygen Saturation in Geriatric Patients Undergoing Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03349658
- Acronym / sponsor ID
- AntalyaTRH 17
- Conditions
- Disorder of Hip Joint
- Keywords
- total hip arthroplasty, cerebral oxygen saturation, general anesthesia, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Geriatric patients who received anesthesia undergoing total hip arthroplasty were randomized by means of a computer-generated randomization order into two groups; general anesthesia group (Group 1) and spinal anesthesia group (Group 2). Before and after induction of the general or spinal anesthesia, patients were monitorized with near infrared spectroscopy for regional cerebral oxygen saturation. Findings were compared statistically.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | Active comparator | Other: general anesthesiaPatients in this group were randomized to receive general anesthesia. |
| spinal anesthesia | Active comparator | Other: spinal anesthesiaPatients in this group were randomized to receive spinal anesthesia. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patients who undergo elective total hip arthroplasty
- American Society of Anesthesiologists class 1 to 3
- Ability to consent
Key exclusion criteria (5 listed)
- Pulmonary disease
- History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Neurologic disease
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anesthesiaeffect of general anesthesia on transcranial regional cerebral oxygen saturation | Other | general anesthesia |
| spinal anesthesiaeffect of spinal anesthesia on transcranial regional cerebral oxygen saturation | Other | spinal anesthesia |
Primary outcome
Change in transcranial regional cerebral oxygenation (rSO2)
Time frame: 60 minutes
Assessed every 5 minutes during the procedure
1 secondary outcome
Post anesthetic complications
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozge Dagdelen, MD study director
Antalya Training and Research Hospital
Nilgun Kavrut Ozturk, MD principal investigator
Antalya Training and Research Hospital
Ali Sait Kavakli, MD principal investigator
Antalya Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing general anesthesia and spinal anesthesia in people with Disorder of Hip Joint, run by Antalya Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transcranial regional cerebral oxygenation (rSO2) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.