Prevention of Postoperative Nausea and Vomiting

• ClinicalTrials.gov Identifier: NCT02382146
• Recruitment Status: Completed
• First Posted: March 6, 2015
• Last Update Posted: November 21, 2017
• Sponsor: Yeditepe University Hospital
• Information provided by (Responsible Party): nurcan kizilcik, Yeditepe University Hospital

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Turkey

Turkey

Istanbul, Kadıkoy, Turkey, 34752

Sponsors and Collaborators

Yeditepe University Hospital

Investigators

• Principal Investigator: nurcan kızılcık; yeditepe UH

More Information

• Responsible Party: nurcan kizilcik, Dr., Yeditepe University Hospital
• ClinicalTrials.gov Identifier: NCT02382146
• Other Study ID Numbers: yeditepe universty hospital
• First Posted: March 6, 2015
• Last Update Posted: November 21, 2017
• Last Verified: November 2017

Additional relevant MeSH terms:

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