Completed

ANPATHYAntagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia.

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What is being tested

ondansetron

+ Droperidol

+ Dexamethasone

Drug
Who is being recruted

From 18 to 70 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2009
See protocol details

Summary

Principal SponsorUniversity Hospital, Lille
Last updated: October 27, 2016
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Study start date: June 1, 2009

Actual date on which the first participant was enrolled.

It was shown that there was an antagonism of the ondansetron on the analgesia led by acetaminophen in a model of nociception by electrical stimulation using the PainMatcher in healthy volunteers. Our study try to determinate if a such antagonism exist in clinical conditions : 66 patients with an Apfel-score II undergoing thyroidectomy were randomized in 3 equal groups. Each group received an antiemetic (ondansetron, droperidol or dexamethasone) at the begining of the intervention and paracetamol at the end of the intervention for the postoperative analgesia. During 2 hours in the postoperative unit, we raised : the electrical pain's threshold with the PainMatcher, the numeric pain intensity scale and the presence of nausea or vomiting. For each patients we determined the cytochrome P450 2D6 activity that should have been able to explain a diminution of ondansetron's efficiency. Paracetamol blood levels were also raised in the postoperative unit.

NCT01679093
Principal SponsorUniversity Hospital, Lille
Last updated: October 27, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
American Society of Anesthesiologists physical status from I to III
Apfel-score equal to 2
informed consent signed
patients undergoing thyroidectomy without lymph node dissection
9 exclusion criteria prevent from participating
addictive disorders
administration of glucocorticoid for protecting recurrent laryngeal nerve
allergy or contra-indication to a drug used in the study
intellectual handicap
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
patients receiving ondansetron at the beginning of the surgery to prevent postoperative nausea and vomiting (PONV); and paracetamol at the end of the surgery for postoperative analgesia.

Group II

Active Comparator
patients receiving droperidol at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.

Group III

Active Comparator
patients receiving dexamethasone at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hôpital Claude Huriez, CHRU

Lille, FranceOpen Hôpital Claude Huriez, CHRU in Google Maps
CompletedOne Study Center