Anesthesia, GeneralNCT05409885
The Effect of General and Spinal Anesthesia on Neutrophil-to-lymphocyte Ratio
An observational study of Anesthesia, General and Anesthesia, Spinal, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and mean platelet volume (MPV) in patients undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anesthesia, General, Anesthesia, Spinal, Umbilical Cord
- What is being tested?
- General anesthesia and Spinal anesthesia
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2022to 7 Jul 2022
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: elective ceserean surgery
Who may be able to join
- 18 - 45 years
- American Society of Anesthesiology (ASA) II-III
- elective ceserean surgery
Who cannot join
- declining to give written informed consent
- under 18 years of age or over 45 years of age
- factors affecting NLR, PLR and MPV such as preeclampsia, HELLP syndrome or premature rupture of membranes
- history of neurological and/or neuromucular disease
- cooperation cannot be established
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100
About this study
Official title: Comparison of the Effect of General and Spinal Anesthesia on Umbilical Neutrophil-to-lymphocyte Ratio, Platelet-to-lymphocyte Ratio and Mean Platelet Volume in Patients Undergoing Cesarean Section
The aim of the study was to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and mean platelet volume (MPV) in patients undergoing cesarean section.
Read the detailed description
This study was designed to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord NLR, PLR and MPV in patients undergoing cesarean section.
The primary endpoint was to compare the effects of general and spinal anesthesia on umbilical cord NLR. Secondary endpoints were determined the general and spinal anesthesia on routine umbilical cord PLR, MPV and newborn Apgar scores at 1st and 5th min.
- Conditions
- Anesthesia, General, Anesthesia, Spinal, Umbilical Cord
- Being tested
- General anesthesia, Spinal anesthesia
- Keywords
- anesthesia, cesarean section, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, mean platelet volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaOther
Evaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.
Spinal anesthesiaOther
Evaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia group | Evaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section. Receives: Other: General anesthesia | |
| Spinal anesthesia group | Evaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section. Receives: Other: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil-to-lymphocyte ratio
Evaluate the effects of NLR in patients undergoing cesarean section
Measured: within 5 minute, following delivery
Secondary outcomes (4)
platelet-to-lymphocyte ratio
Evaluate the effects of PLR in patients undergoing cesarean section
Measured: within 5 minute, following delivery
mean platelet volume
Evaluate the effects of MPV in patients undergoing cesarean section
Measured: within 5 minute, following delivery
Newborn Apgar score 1st minute
Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (tone), Respiration. Apgar score at 1st min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
Measured: 1st minute after birth
Newborn Apgar score 5th minute
Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (tone), Respiration. Apgar score at 1st min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
Measured: 5th minute after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start20 Mar 2022
- Primary completion1 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kerem İnanoğlu, Principal investigator, Antalya TRHEsra Bağ, Principal investigator, Antalya TRHArzu Karaveli, Study director, Antalya TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409885
- Sponsor's protocol ID
- 5/4
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of General and Spinal Anesthesia on Umbilical Neutrophil-to-lymphocyte Ratio, Platelet-to-lymphocyte Ratio and Mean Platelet Volume in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT05409885
- Acronym / sponsor ID
- 5/4
- Conditions
- Anesthesia, General, Anesthesia, Spinal, Umbilical Cord
- Keywords
- anesthesia, cesarean section, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, mean platelet volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 8 Jun 2022 (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 aim of the study was to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and mean platelet volume (MPV) in patients undergoing cesarean section.
Detailed description
This study was designed to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord NLR, PLR and MPV in patients undergoing cesarean section.
The primary endpoint was to compare the effects of general and spinal anesthesia on umbilical cord NLR. Secondary endpoints were determined the general and spinal anesthesia on routine umbilical cord PLR, MPV and newborn Apgar scores at 1st and 5th min.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia group | – | Other: General anesthesiaEvaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section. |
| Spinal anesthesia group | – | Other: Spinal anesthesiaEvaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- elective ceserean surgery
Key inclusion criteria (3 listed)
- 18 - 45 years
- American Society of Anesthesiology (ASA) II-III
- elective ceserean surgery
Key exclusion criteria (6 listed)
- declining to give written informed consent
- under 18 years of age or over 45 years of age
- factors affecting NLR, PLR and MPV such as preeclampsia, HELLP syndrome or premature rupture of membranes
- history of neurological and/or neuromucular disease
- cooperation cannot be established
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 anesthesiaEvaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section. | Other | General anesthesia group |
| Spinal anesthesiaEvaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section. | Other | Spinal anesthesia group |
Primary outcome
neutrophil-to-lymphocyte ratio
Time frame: within 5 minute, following delivery
Evaluate the effects of NLR in patients undergoing cesarean section
4 secondary outcomes
platelet-to-lymphocyte ratio
Time frame: within 5 minute, following delivery
mean platelet volume
Time frame: within 5 minute, following delivery
Newborn Apgar score 1st minute
Time frame: 1st minute after birth
Newborn Apgar score 5th minute
Time frame: 5th minute after birth
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 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Kerem İnanoğlu principal investigator
Antalya TRH
Esra Bağ principal investigator
Antalya TRH
Arzu Karaveli study director
Antalya TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General and Anesthesia, Spinal, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 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 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
neutrophil-to-lymphocyte ratio (time frame: within 5 minute, following delivery). 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 Jul 2022.