The Relationship Between Abdominal Circumference: Hip Ratio and Ephedrine Requirement

NCT05382624 | Completed

• 1 other identifier: BEAH KAEK 2021/05-100
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aimed to investigate whether there is a relationship between weight, height, BMI, abdominal circumference (AC), hip circumference (HC), and AC-to-hip ratio with the incidence of hypotension in patients undergoing cesarean section under spinal anesthesia.

Conditions

Hypotension; Anesthesia, Local; Cesarean Section Complications

Keywords

hypotension; spinal anesthesia; cesarean section; ephedrine requirement; abdominal circumference; hip circumference,

Outcome Measures

Primary Outcomes (1)

• Ephedrine requirement

  Ephedrine requirement (mg) from the beginning to the end of the surgery.

  Two hours.

Secondary Outcomes (2)

• atropine requirement

  Two hours.

• Blood pressure values

  Baseline, during surgery.

Study Arms (1)

Patients undergoing cesarean with spinal anesthesia

The AC-to-hip ratio was calculated by dividing the values of the abdominal (cm) and hip circumference (cm). Spinal anesthesia in the sitting position was performed in all patients using 2.4 ml 0.5% hyperbaric bupivacaine (12 mg). Intravenous ephedrine (5 mg) was given in case of persistent hypotension. The number of patients requiring ephedrine and the total amount of ephedrine used during surgery were recorded.

Procedure: Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration.

Interventions

Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration. PROCEDURE

The operation time (the time from the beginning of the surgical incision until the end of surgery), anesthetic complications, such as nausea or vomiting, the number of patients requiring ephedrine and atropine, the total amount of intravenous fluid used, and the total amount of ephedrine used during surgery were recorded.

Also known as: Hip circumference was measured at the widest circumference over the buttocks., Three consecutive measurements were obtained; results were averaged and the AC-to-hip ratio was calculated by dividing the values of the abdominal (cm) and hip circumference (cm)., Spinal anesthesia in the sitting position was performed on all patients., After surgery, patients were transferred to the recovery room.

Patients undergoing cesarean with spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with uncomplicated term pregnancy
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population comprised 60 women who agreed to participate with uncomplicated term pregnancies, BMI \< 30 kg/m2, aged between 18-45 years, ASA I and II undergoing elective cesarean section under spinal anesthesia.

You may qualify if:

• women who agreed to participate
• with uncomplicated term pregnancies
• BMI \< 30 kg/m2
• aged between 18-45 years
• ASA I and II
• undergoing elective cesarean section under spinal anesthesia

You may not qualify if:

• a complicated pregnancy, such as diabetes, hypertension, fetal anomaly
• a history of allergy to study drugs
• psychiatric diseases
• coagulation abnormalities
• multiple pregnancies
• patients who required conversion to general anesthesia

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Mehmet Aksoy

Erzurum, string:Turkey, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Interventions

Anesthesia, Spinal; Postoperative Period

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Abdullah CAN, MD

  Erzurum Regional Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ayse N DAS, MD

  Erzurum Regional Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 19, 2022
• Study Start: April 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: January 1, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)