Prevention of Postoperative Nausea and Vomiting
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|ClinicalTrials.gov Identifier: NCT02382146|
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting||Drug: dexamethasone ondansetron Drug: Dexamethasone dimenhidrinate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Randomize Study: Prevention of Nausea and Vomiting in Plastic Surgery|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: dexamethasone and ondansetron
dexamethasone 8 mg with ondansetron 4mg administered in group DO
Drug: dexamethasone ondansetron
dexamethasone 8 mg intravenous ondansetron 4 mg intravenous dimenhydrinate 1mg/kg intravenous
Other Name: dekort zofer dramamine
Active Comparator: dexamethasone and dimenhydrinate
dexamethasone 8 mg with dimenhydrinate 1mg/kg administered in group DD
Drug: Dexamethasone dimenhidrinate
dexamethasone 8 mg intravenous dimenhydrinate 1mg/kg intravenous
Other Name: dekort dramamin
- prevention of postoperative nausea and vomiting [ Time Frame: 1 year ]The primary outcome is complete response: complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382146
|Istanbul, Kadıkoy, Turkey, 34752|
|Principal Investigator:||nurcan kızılcık||yeditepe UH|