Prevention of Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      We designed this randomized, double- blind, single-center study to compare the efficacy of
      the combination of dexamethasone with ondansetron and dexamethasone with dimenhydrinate
      undergoing plastic surgery.
    

Detailed description: 
      A total of 60 voman patient, ASA status I-II , aged 18-65 year and scheduled for elective
      rhinoplasty were enrolled in the study. Exclusion criterias hypersensitivity or
      contraindication for the studied medications, received an antiemetic drug or steroid within
      24 hours before anesthesia, have history of diabetes history of motion sickness (MS) or PONV,
      or pregnant and lactating females.

      Patients were informed on how to use the patient controlled analgesia device during the
      postoperative period. The risk criterias for PONV were recorded for each patient.Patients
      were randomly assigned to two study groups of 30 patients. All patients were premedicated
      with intravenous (iv) midazolam (1-2 mg). On arrival in the operating room, standard
      anesthetic monitors were applied. Anesthesia was induced with iv propofol (2-3 mg/kg) and
      fentanyl (1-1.5 μg/kg). Tracheal intubation was facilitated with rocuronium (0.6 mg/kg).
      After tracheal intubation all patient received iv 8 mg dexamethasone. Normocapnic mechanical
      ventilation was performed after intubation. General anesthesia was maintained with
      sevoflurane (1 minimum alveolar concentration) in oxygen / air mixture and remifentanil
      (0.1-0.3 μg/kg/min) infusion.Four mg ondansetron and for each patient 1 mg/kg dimenhydrinate
      in the 5 ml syringe solution were prepared by pharmacy department, and given to the blinded
      investigators. The patients, anesthesiologists (with the exception of the primary author),
      statistician, and observes were all blinded.

      Dimenhydrinate was administered in group DD (1mg/kg), and ondansetron was administered in
      group DO (4mg), and all patients received tramadol (1.5mg/kg) and tenoksikam (20mg) half an
      hour before emergence.

      Postoperative analgesia was provided with a patient controlled analgesia system by using iv
      tramadol (5mg/mL) (2 ml bolus and 10 minutes lockout interval without basal infusion).

      After the surgery, muscle relaxation was reversed by administering neostigmine (0.05mg/kg)
      and atropine (0.015mg/kg). Patients were extubated and transferred to the recovery unit.
    

Intervention name(s): dexamethasone ondansetron; Dexamethasone dimenhidrinate
Intervention type(s): Drug; Drug
Intervention description(s): dexamethasone 8 mg intravenous ondansetron 4 mg intravenous dimenhydrinate 1mg/kg intravenous; dexamethasone 8 mg intravenous dimenhydrinate 1mg/kg intravenous
Other intervention name(s): dekort zofer dramamine; dekort dramamin
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention