The Effect of General and Spinal Anesthesia on Neutrophil-to-lymphocyte Ratio

July 20, 2022 updated by: Antalya Training and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07100
        • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

elective ceserean surgery

Description

Inclusion Criteria:

  • 18 - 45 years
  • American Society of Anesthesiology (ASA) II-III
  • elective ceserean surgery

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anesthesia group
Evaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.
Other: General anesthesia
Evaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.
Spinal anesthesia group
Evaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.
Other: Spinal anesthesia
Evaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neutrophil-to-lymphocyte ratio
Time Frame: within 5 minute, following delivery
Evaluate the effects of NLR in patients undergoing cesarean section
within 5 minute, following delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
platelet-to-lymphocyte ratio
Time Frame: within 5 minute, following delivery
Evaluate the effects of PLR in patients undergoing cesarean section
within 5 minute, following delivery
mean platelet volume
Time Frame: within 5 minute, following delivery
Evaluate the effects of MPV in patients undergoing cesarean section
within 5 minute, following delivery
Newborn Apgar score 1st minute
Time Frame: 1st minute after birth
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)
1st minute after birth
Newborn Apgar score 5th minute
Time Frame: 5th minute after birth
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)
5th minute after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Principal Investigator: Kerem İnanoğlu, Antalya TRH
  • Principal Investigator: Esra Bağ, Antalya TRH
  • Study Director: Arzu Karaveli, Antalya TRH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2022

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 7, 2022

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

June 4, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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