Prevention of Postoperative Nausea and Vomiting

NCT02382146 | Completed Phase 4

• 1 other identifier: yeditepe universty hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• prevention of postoperative nausea and vomiting

  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.

  1 year

Study Arms (2)

dexamethasone and ondansetron

EXPERIMENTAL

dexamethasone 8 mg with ondansetron 4mg administered in group DO

Drug: dexamethasone ondansetron

dexamethasone and dimenhydrinate

ACTIVE COMPARATOR

dexamethasone 8 mg with dimenhydrinate 1mg/kg administered in group DD

Drug: Dexamethasone dimenhidrinate

Interventions

dexamethasone ondansetron DRUG

dexamethasone 8 mg intravenous ondansetron 4 mg intravenous dimenhydrinate 1mg/kg intravenous

Also known as: dekort zofer dramamine

dexamethasone and ondansetron

Dexamethasone dimenhidrinate DRUG

dexamethasone 8 mg intravenous dimenhydrinate 1mg/kg intravenous

Also known as: dekort dramamin

dexamethasone and dimenhydrinate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years to 60 Years woman
• ASA (American Society of Anesthesiologist) physical status I or II
• Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University Hospital: lead

Study Sites (1)

Turkey

Istanbul, Kadıkoy, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• nurcan kızılcık

  yeditepe UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 6, 2015
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

TU (1)