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

Tracking Information

• First Submitted Date: February 24, 2015
• First Posted Date: March 6, 2015
• Last Update Posted Date: November 21, 2017
• Study Start Date: April 2012
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 2, 2015)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention of Postoperative Nausea and Vomiting
• Official Title: A Prospective Randomize Study: Prevention of Nausea and Vomiting in Plastic Surgery
• 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.

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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Postoperative Nausea and Vomiting

Intervention

• Drug: dexamethasone ondansetron
  dexamethasone 8 mg intravenous ondansetron 4 mg intravenous dimenhydrinate 1mg/kg intravenous
  Other Name: dekort zofer dramamine
• Drug: Dexamethasone dimenhidrinate
  dexamethasone 8 mg intravenous dimenhydrinate 1mg/kg intravenous
  Other Name: dekort dramamin

Study Arms

• Experimental: dexamethasone and ondansetron
  dexamethasone 8 mg with ondansetron 4mg administered in group DO
  Intervention: Drug: dexamethasone ondansetron
• Active Comparator: dexamethasone and dimenhydrinate
  dexamethasone 8 mg with dimenhydrinate 1mg/kg administered in group DD
  Intervention: Drug: Dexamethasone dimenhidrinate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2015): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT02382146
• Other Study ID Numbers: yeditepe universty hospital
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: nurcan kizilcik, Yeditepe University Hospital
• Study Sponsor: Yeditepe University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: nurcan kızılcık; yeditepe UH

• PRS Account: Yeditepe University Hospital
• Verification Date: November 2017