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HypotensionNCT05382624

The Relationship Between Abdominal Circumference: Hip Ratio and Ephedrine Requirement

An observational study of Hypotension and Anesthesia, Local, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration.
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2020to 1 Jan 2021
How long will I take part?
1 Day
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
  • Women only
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mehmet Aksoy

    Erzurum, string:Turkey, 25240

Other trials in Turkey (Türkiye)

About this study

Official title: The Relationship Between Abdominal Circumference: Hip Ratio and Ephedrine Requirement in Spinal Anesthesia for Elective Cesarean: A Prospective Observational Study

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.

Read the detailed description

This prospective observational study was conducted over eight months from March 2021 to October 2021 at the Anesthesiology and Reanimation Department of Erzurum Regional Training and Research Hospital, Erzurum, Turkey, a tertiary care hospital. Before commencing the study, the Institute ethics committee approval was taken from the Ethical Committee of Health Sciences University, Erzurum Regional Training and Research Hospital, Erzurum, Turkey. This study was carried out in accordance with the Declaration of Helsinki and written informed consent was obtained from all participants.

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. Participants with a complicated pregnancy, such as diabetes, hypertension, fetal anomaly, a history of allergy to study drugs, psychiatric diseases, coagulation abnormalities, and mul¬tiple pregnancies were excluded from the study. Also, patients who required conversion to general anesthesia were excluded.

A day before surgery, patients were informed about the study, and written informed consent was obtained from participants. On the day of the operation, all participants were preloaded with 500 milliliters of Ringer's lactate through a 16-18 gauge intravenous cannula. In the operating room, standard monitorization including non-invasive blood pressure, electrocardiography, and pulse oximetry was provided. Before the spinal anesthesia, patients' age, weight, height, abdominal and hip circumferences, ASA physical status, baseline values of noninvasive blood pressure, and heart rate (HR) were recorded.

Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration. Hip circumference was measured at the widest circumference over the buttocks. All the measurements were carried out by the trained anesthesia technician using standard non-stretch tape with the parturients wearing light clothes. To minimize errors, 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. Following skin sterilization, a 27-gauge Quincke-tip spinal needle was advanced through the midline L3-4 intervertebral space. After free cerebrospinal fluid flow was observed, 2.4 ml 0.5% hyperbaric bupivacaine (12 mg) was injected over 30 seconds. Then, the spinal needle was removed and patients were placed in the supine position for the operation, and the operating table was tilted 20° to the left. A pinprick test was used to evaluate the sensory block level and surgery was initiated when the sensory block reached the T6 dermatome. Spinal anesthesia was considered to have failed when the sensory block was not consistent within the first 20 minutes following the spinal injection. In this instance, general anesthesia was performed and these patients were excluded from the study. A Modified Bromage scale was used to evaluate the motor block level. After delivery of the baby, 20 IU oxytocin in 1000 ml Ringer's lactate solution was given intravenously over 5 hours. Hypotension (a 20% decrease in systolic blood pressure compared to preoperative values), was treated by uterine displacement and rapid infusion of fluid. Intravenous ephedrine (5 mg) was given in case of persistent hypotension. Intravenous atropine (1 mg) was injected to treat bradycardia (the HR < 45 beats/minute). In our clinic, ephedrine is routinely used as the first choice in the treatment of hypotension. Intravenous ondansetron (4 mg) was used to treat persistent nausea and vomiting. Following spinal injection, systolic, diastolic, and mean arterial pressure and HR values were recorded every 2 minutes for 20 minutes and then every 5 minutes until the end of the operation. 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. Neonatal Apgar scores at 1 and 5 minutes after delivery and the weight and height of the neonates were recorded. After surgery, patients were transferred to the recovery room. Pain severity was assessed via the Visual analog scale (VAS, 0 cm=no pain, 10 cm=worst pain). In the case of VAS > 3, 1 gr paracetamol was given to patients intravenously. Anesthesia-related side effects (e.g., nausea, vomiting, and headache), sensory block time (from the spinal injection to the recovery of T10 dermatome), and the time requiring supplemental analgesics was recorded by an independent observer blinded to the group assignment at 30 min and 1st and 2nd hours post-operatively. When the motor block had regressed to the T10 level, patients were sent to the clinics.

Statistical Analysis The sample size calculation was performed based on the data gained from the study's preliminary results using Russ Lenth's power and sample size calculation application (13). Fifty-eight patients were needed to detect an anticipated effect size of 0.37 with a power of 85% and an alpha of 5%.

The statistical analysis of all data was performed with SPSS 20 software (SPSS Inc., Chicago, IL, USA), and P<0.05 was considered statistically significant. Data were expressed as mean values ± standard deviation (SD), median (min-max), or number and percentage values. Kolmogorov-Smirnov test was used to detect the distribution of data.

Pearson correlation analysis was performed to assess the association between anthropometric measures (i.e., BMI, AC-to-hip ratio) with the incidence of hypotension and the total amount of ephedrine used. Correlation analysis was performed to find the correlations between the total amount of ephedrine used and the AC, HC, and AC-to-hip ratio. The correlation between the total amount of ephedrine used and the weight of the fetus was also investigated. The regression equations were obtained by using the linear regression method and the coefficients (r2) were compared.

Being tested
Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration.
Keywords
hypotension, spinal anesthesia, cesarean section, ephedrine requirement, abdominal circumference, hip circumference,
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called 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.

    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.

Study groups in NCT05382624
Study groupRoleWhat they receive
Patients undergoing cesarean with spinal anesthesiaThe 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.
Receives: Procedure: Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ephedrine requirement

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

    Measured: Two hours.

Secondary outcomes (2)
  1. atropine requirement

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

    Measured: Two hours.

  2. Blood pressure values

    The change in systolic and diastolic blood pressure values (mmHg).

    Measured: Baseline, during surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start1 Apr 2020
  3. Primary completion30 Oct 2020
  4. Study completion1 Jan 2021

Resources

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 only
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382624
Sponsor's protocol ID
BEAH KAEK 2021/05-100
Status last verified
May 2022
First submitted
7 May 2022
Last updated
19 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypotension and Anesthesia, Local, run by Ataturk University 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 6 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 19 May 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?

Ephedrine requirement (time frame: Two hours.). 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 19 May 2022.

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