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Prevention of Postoperative Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02382146
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
nurcan kizilcik, Yeditepe University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: dexamethasone ondansetron Drug: Dexamethasone dimenhidrinate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Locations
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Turkey
Turkey
Istanbul, Kadıkoy, Turkey, 34752
Sponsors and Collaborators
Yeditepe University Hospital
Investigators
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Principal Investigator: nurcan kızılcık yeditepe UH
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Responsible Party: nurcan kizilcik, Dr., Yeditepe University Hospital
ClinicalTrials.gov Identifier: NCT02382146    
Other Study ID Numbers: yeditepe universty hospital
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Ondansetron
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents