Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04613726 |
| Other study ID # |
B.30.2.ATA.0.01.00/166 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
December 3, 2018 |
| Est. completion date |
January 1, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study compared the effects of prophylactic intravenous (IV) infusion of ondansetron and
granisetron before the spinal anesthesia on hemodynamic parameters in patients undergoing
elective cesarean section.
Description:
A total of 120 parturients who agreed to participate in the study with uncomplicated term
pregnancy, aged between 18-45 years, American society of anesthesiologist I or II undergoing
elective cesarean section with combined spinal-epidural anesthesia (CSEA) were included.
Participants with complicated pregnancy such as diabetes, pregnancy-induced hypertension or
chronic 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 receiving selective serotonin reuptake inhibitors were excluded.
A day before surgery, detailed anamnesis was obtained from the patients and a general
systemic examination was performed. Also, patients were informed about the study protocol and
written informed consent was obtained. The patients were informed that they should be fasting
for 8 hours before surgery. On the day of operation, peripheral intravenous (IV) access was
provided using a 16-gauge/18-gauge cannula.
After all patients received 500 ml of Ringer Lactate as preload, they were transferred to the
operating room. None of the patients received premedication. Before the anesthesia procedure;
patients' age, weight, height, ASA physical status, baseline systolic blood pressure (SBP),
diastolic blood pressure (DBP) and heart rate (HR) were recorded. The study medications were
prepared by an anesthesia resident who was not involved in the study. Three groups (n=40, for
each group) were formed by randomization using a computer-generated table of random numbers.
The anesthesiologist in charge, and the patient and investigators were blinded to the group
allocation.
Five minutes before the CSEA procedure, Group I received IV 8 mg ondansetron diluted in 10 ml
of normal saline, Group II received IV 3 mg granisetron diluted in 10 ml of normal saline,
and Group III received IV 10 ml normal saline. Subsequently, combined spinal-epidural
anesthesia (CSEA) in the sitting position was performed in all patients. Following skin
sterilization and local anesthetic infiltration (2% lidocaine), 18 gauge Tuohy needle (Set
for CSEA, Braun®, Melsungen, Germany) was advanced through the midline L2-3 or L3-4
intervertebral spaces with loss of resistance technique. A 27-gauge pencil point needle was
inserted intrathecally, using the needle-through-needle technique. After free cerebrospinal
fluid flow was observed, 1.8 ml 0.5% isobaric bupivacaine (9 mg) and 15 µg fentanyl was
administered over 30 seconds. Then, the spinal needle was removed and epidural catheter was
advanced 3 to 5 cm into the epidural space. The catheter was secured in place after it was
checked with negative pressure. At the end of the anesthesia procedure, patients were placed
in the supine position for operation and the operating table was tilted 20° to the left.
Sensory block level was evaluated via pinprick test and when the sensory block reached at the
upper level of T6 dermatome, surgery was initiated. If sensory block were not observed within
the first 20 min following the spinal injection, spinal anesthesia was considered as failed.
In this instance, additional 5 ml solution of 2% lidocaine was injected via the epidural
catheter until a T6 level of the sensory block was provided and these patients were excluded
from the study. Motor block level was evaluated with Modified Bromage scale (scale 0 = The
patient is able to move hip, knee, ankle, and toes.; scale 1 = The patient is able to the
full flexion of foot and knee, she is unable to hip flexion; scale 2 = The patient is able to
the full flexion of foot, she is unable to knee and hip flexion; scale 3 = Total motor block
is available). General anaesthesia protocol was planned in case of three unsuccessful
attempts to reach to intrathecal space. Oxygen was delivered during surgery. Intravenous
ephedrine (6 mg) was planned to treat hypotension (a 30% decrease in systolic blood pressure
compared to preoperative values) and intra¬venous atropine (1 mg) was planned in case of
bradycardia (the heart rate < 45 beats/minute) during surgery. In case of nausea and
vomiting, intravenous metoclopramide (10 mg) was administered. Following drug administration
to the intrathecal space, intraoperative hemodynamic changes were recorded every 2 min for 20
min and then every five minutes until the end of the operation by an anesthetist who was
blinded to the group allocation. The operation time (the time from the beginning of the
surgical incision until the end of surgery), anesthetic complications such as pruritus and
nausea-vomiting and the number of patients requiring epidural medication, ephedrine and
atropine during surgery were recorded. Neonatal Apgar scores at 1 and 5 min after delivery
and umbilical artery blood gas values were recorded.
After operation, patients were evaluated in the recovery room for 120 min. Visual analogue
scale (VAS, 0 cm= no pain, 10 cm= worst pain) scores for pain severity, 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. In the case of VAS > 3 in a patient, 10 ml solution of 0.1%
bupivacaine was given via the epidural catheter. Patients were transferred to the ward,
following the motor block had regressed to the T10 level.
The primary end point of the study was the ephedrine requirement during surgery. The minimum
sample size required for this study was calculated using the Russ Lenth's Power and sample
size calculation application. Thirty-five patients in each group were needed to demonstrate a
mean difference in the requirement of 10 mg ephedrine among groups with a power of 90% and
alpha 5%. However, a sample size was determined as 40 in each group, considering potential
dropouts.
Data were expressed as mean values ± standard deviation (SD) or number and percentage values.
Comparisons were performed using the ANOVA test. The percentage values were compared using
chi-square, P<0.05 was considered significant statistically.
