Intrathecal Atropine Versus Intravenous Metoclopramide for Prevention of Nausea and Vomiting During Caesarian Section Under Spinal Anesthesia
Description:
Patients After obtaining the approval of the Mansoura Faculty of Medicine Institutional
Research Board (MFM-IRB) and registration with ClinicalTrials.gov, this prospective double
blind randomized study will be conducted in the next 6 months on 100 pregnant women
undergoing elective CS in obstetric surgery unit in Mansoura University Hospital, Mansoura,
Egypt. A written informed consent will be taken from each patient selected to participate
before inclusion in the study.
Inclusion criteria Patients with ASA physical status class I or II; indications for CS other
than fetal or maternal pathology and surgery scheduled for within 4 days of physiological
term will be included in this study.
Exclusion criteria Patients with any of the following criteria will be excluded from the
study: 1) age < 20 or > 35 years; 2) height < 150 or > 180 cm; 2) body mass index (BMI) >35
kg/m2; 4) active labor or emergency CS; 5) emesis gravidarum; 6) multifetal pregnancy; 7)
fetal distress; 8) associated medical problem with pregnancy (as hypertension, diabetes
mellitus, hepatic impairment or renal impairment);9) obstetric problem (as placenta previa or
placental abruption); 10) contraindication for central neuraxial block; 11) history of
adverse reaction to any study medication; 12) history of antiemetic drug use; or 13) refusal
to undergo regional anesthesia.
Methods All patients participating in the study will be randomly divided into two groups;
atropine group and metoclopramide group. The randomization will be simple and balanced (1:1)
and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing
computer-generated random numbers. The participants, caregivers and investigators will be
blinded to group assignment. Patients in the atropine group will receive IV study solution
which is 2 ml saline 0.9% as a placebo + intrathecal study solution which is a premised
solution of 2.5 ml of 0.5% hyperbaric bupivacaine, 25 μg fentanyl and 100 μg of a 1 mg/ml
preservative-free atropine sulfate solution. Patients in the metoclopramide group will
receive IV study solution which is metoclopramide 10 mg in 2 ml + intrathecal study solution
which is a premised solution of 2.5 ml of 0.5% hyperbaric bupivacaine, 25 μg fentanyl and 100
μg of preservative-free saline 0.9% as a placebo.
All participants will be instructed to stop oral intake 8 hours before surgery, but they will
be allowed to drink moderate amounts of water and juices until 6 hours before surgery.
Anesthesia protocol will be standardized in all patients. On arrival of the patient to
operative theatre, intravenous (IV) cannula will be inserted and IV infusion of Ringer’s
acetate (8 ml/kg) will be given over about 20 minutes as a fluid preload before anesthesia.
Patients will receive the IV study solution (according to their allocation) 15 minutes before
start of anesthesia procedures. The spinal anesthesia will be performed in sitting position
under strict aseptic condition. The anesthesia will be given at the level of L2-L3 or L3-L4
with a 25-gauge whit acre needle. Injections will be made using three separate syringes.
Patients will be placed in a supine position immediately after the end of injections. A left
lateral posture will be applied to all patients.
Sensory block will be assessed every 2 minute after intrathecal injection by using analgesia
to pinprick in midclavicular line until achieving a stable level of sensory block. Surgery
will be permitted after achieving T6 sensory block level. If the sensory level will not reach
this level this case will be excluded from the study, and general anesthesia will be then
given. Motor block will be assessed by using modified Bromage score (BS) in which, BS0 means
no motor block; BS1 means inability to raise extended legs; BS2 means inability to flex
knees; BS3 means inability to flex ankle joints. Complete motor block will be defined as BS3.
Heart rate, noninvasive arterial blood pressure and peripheral oxygen saturation (SpO2)
measurements will be assessed in both groups preoperatively, during shifting and every 10
minutes intraoperatively. Hypotension will be defined as systolic blood pressure < 100 mmHg
or > 30% decrease in baseline values. Bradycardia will be defined as heart rate < 60 bpm or a
20% drop in heart rate. Hypotension will be treated initially by bolus IV infusion of
crystalloids (300 ml) then IV ephedrine 5 mg will be administered as needed. Bradycardia will
be treated with fluids, positioning and ephedrine (up to 25 mg).If bradycardia does not
resolve within seconds of treatment, IV atropine sulphate 0.5 mg will be given every 30
seconds until resolution. Patients who will receive IV atropine in addition to the study dose
will be excluded from the study. After delivery, bradycardia will be only treated if
hypotension is also present, or when the heart rate is <60 bpm.
Outcome measures The main outcome measure will be occurrence of IONV or PONV. Any IONV or
PONV rating > 3 or spontaneous reporting of IONV or PONV by patients during scheduled
interviews, as well as any clinical manifestations (retching or vomiting) and any requests
for antiemetic medication will be considered as episodes of NV. Other outcome measures will
be pain at rest, hypotension, bradycardia, shivering, pruritus, unexplained anxiety,
xerostomia, photophobia, and the time of the first request for antiemetic drugs and
analgesics and the number of requests until 12 h postoperatively.
Statistical analysis The statistical analysis will be performed using the IBM® SPSS®
Statistics, version 20.0 for Windows. Continuous variables will be expressed as mean ±
standard deviation (SD) and categorical variables will be expressed as frequencies and
percentages. The normality distribution of continuous variables will be tested with the
Kolmogorov-Smirnov and Shapiro-Wilk tests. Differences among continuous variables with normal
distribution will be compared with the t-test while for continuous variables without normal
distribution, non-parametric tests will be used and differences will be compared with the
Mann-Whitney U-test. Differences between percentages will be compared with the Fisher’s exact
test. P values ≤ 0.05 will be considered statistically significant.
Condition:
Nausea
Treatment:
Atropine sulfate
Start Date:
May 5, 2019
Sponsor:
Mansoura University
For More Information:
https://clinicaltrials.gov/show/NCT03932578