Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05382624 |
| Other study ID # |
BEAH KAEK 2021/05-100 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2020 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
