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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05409885
Other study ID # 5/4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2022
Est. completion date July 7, 2022

Study information

Verified date April 2022
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 7, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
General anesthesia
Evaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.
Spinal anesthesia
Evaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.

Locations

Country Name City State
Turkey Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation Antalya

Sponsors (1)

Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary neutrophil-to-lymphocyte ratio Evaluate the effects of NLR in patients undergoing cesarean section within 5 minute, following delivery
Secondary platelet-to-lymphocyte ratio Evaluate the effects of PLR in patients undergoing cesarean section within 5 minute, following delivery
Secondary mean platelet volume Evaluate the effects of MPV in patients undergoing cesarean section within 5 minute, following delivery
Secondary 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) 1st minute after birth
Secondary 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) 5th minute after birth
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