Preemptive Versus Preventive Antiemetic Treatment

October 31, 2018 updated by: Argyro Fassoulaki, University of Athens

Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.

Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.

Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery.

In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Argyro Fassoulaki, MD PhD DEAA
  • Phone Number: 306936701333
  • Email: afassou1@otenet.gr

Study Contact Backup

  • Name: Chryssoula Staikou, MD, PhD, DESA
  • Phone Number: 00306932352742
  • Email: c_staikou@yahoo.gr

Study Locations

  • Greece
    • Attika
      • Athens, Attika, Greece, 11528
        • Aretaieio University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status I-III patients
  • Surgical procedure: scheduled for laparoscopic cholecystectomy
  • Type of anesthesia: general

Exclusion Criteria:

  • Antihistamines the last three days
  • Antiemetic drugs the last three days
  • Hiatus hernia
  • reflux
  • Gastrointestinal disease
  • Pregnancy
  • BMI > 35
  • parkinson
  • known allergy to the drugs of the protocol
  • epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: preemptive group

The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively.

Intervention: Antiemetic treatment 1h before surgery
Other: Antiemetics perioperatively
Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively
Other: intraoperative group

The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes.

Intervention: Antiemetic treatment intraoperatively
Other: Antiemetics perioperatively
Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PONV (postoperative nausea vomiting combined)
Time Frame: 24 hours
Incidence of combined nausea and vomiting postoperatively
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative nausea frequency and intensity
Time Frame: 24 hours
numerical rating scale of nausea intensity (0-10)
24 hours
postoperative vomiting frequency
Time Frame: 24 hours
number of vomits
24 hours
postoperative pain
Time Frame: 24 hours
numerical rating scale of pain intensity (0-10)
24 hours
retching
Time Frame: 24 hours
if retching exists
24 hours
PONV (postoperative nausea vomiting combined)
Time Frame: 24 hours
frequency and intensity of nausea and vomiting
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB No 65/19-06-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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