Prevention of Postoperative Nausea and Vomiting
Information source: Yeditepe University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: dexamethasone ondansetron (Drug); Dexamethasone dimenhidrinate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Yeditepe University Hospital Official(s) and/or principal investigator(s):
nurcan kızılcık, Principal Investigator, Affiliation: yeditepe UH
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.
Clinical Details
Official title: A Prospective Randomize Study: Prevention of Nausea and Vomiting in Plastic Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: prevention of postoperative nausea and vomiting
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Criteria:
Inclusion Criteria:
18 Years to 60 Years woman
ASA (American Society of Anesthesiologist) physical status I or II
Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy
Exclusion Criteria:
Hypersensitivity or contraindication to the study medications,
Antiemetic drug or steroid use within 24 hours before anesthesia,
History of diabetes mellitus,
History of motion sickness or postoperative nausea and vomiting,
Pregnancy,
Breast feeding
Locations and Contacts
Turkey, Istanbul, Kadıkoy 34752, Turkey
Additional Information
Starting date: April 2012
Last updated: March 2, 2015
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