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

• Sponsor: Antalya Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05409885
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 16.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, General; Anesthesia, Spinal; Umbilical Cord	Other: General anesthesia; Other: Spinal anesthesia

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

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Mar 20, 2022
• Actual Primary Completion Date: Jul 1, 2022
• Actual Study Completion Date: Jul 7, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. neutrophil-to-lymphocyte ratio [within 5 minute, following delivery]

   Evaluate the effects of NLR in patients undergoing cesarean section

Secondary Outcome Measures

1. platelet-to-lymphocyte ratio [within 5 minute, following delivery]

   Evaluate the effects of PLR in patients undergoing cesarean section

2. mean platelet volume [within 5 minute, following delivery]

   Evaluate the effects of MPV in patients undergoing cesarean section

3. Newborn Apgar score 1st minute [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)

4. Newborn Apgar score 5th minute [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya		Turkey	07100

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antalya Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05409885
• Other Study ID Numbers: 5/4
• First Posted: Jun 8, 2022
• Last Update Posted: Jul 21, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Antalya Training and Research Hospital: anesthesia; cesarean section; neutrophil-to-lymphocyte ratio; platelet-to-lymphocyte ratio; mean platelet volume
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Jul 21, 2022