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Completed

NCT Number: NCT02382146

Prevention of Postoperative Nausea and Vomiting

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Turkey

Istanbul, Kadıkoy, 34752, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexamethasone ondansetron

Drug

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

Other names: dekort zofer dramamine

Dexamethasone dimenhidrinate

Drug

dexamethasone 8 mg intravenous dimenhydrinate 1mg/kg intravenous

Other names: dekort dramamin

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yeditepe University Hospital

Other

Registry information

Official study title

A Prospective Randomize Study: Prevention of Nausea and Vomiting in Plastic Surgery

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2015
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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