Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the prophylactic use of low dose atropine and comparing
      it to metoclopramide for reducing intraoperative nausea and vomiting during cesarean section
      under spinal anesthesia
    

Detailed 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.
    

Intervention name(s): Atropine sulfate; Metoclopramide
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive intrathecal 100 μg of a 1 mg/ml preservative-free atropine sulfate solution; Patients will receive IV metoclopramide 10 mg in 2 ml
Intervention MeSH terms: Atropine; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cesarean section; Nausea and vomiting; Spinal Anesthesia