Prevention of Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382146
• Other study ID #: yeditepe universty hospital
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2015
• Last updated: November 20, 2017
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2017
• Source: Yeditepe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• dexamethasone ondansetron
dexamethasone 8 mg intravenous ondansetron 4 mg intravenous dimenhydrinate 1mg/kg intravenous
• Dexamethasone dimenhidrinate
dexamethasone 8 mg intravenous dimenhydrinate 1mg/kg intravenous

Locations

Country	Name	City	State
Turkey	Turkey	Istanbul	Kadikoy

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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