Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia. (ANPATHY)

October 26, 2016 updated by: University Hospital, Lille

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

The purpose of our study is to determine if there is an antagonism between drugs used in the prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen after thyroidectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • France
      • Lille, France, 59000
        • Hôpital Claude Huriez, CHRU

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing thyroidectomy without lymph node dissection
  • American Society of Anesthesiologists physical status from I to III
  • Apfel-score equal to 2
  • informed consent signed

Exclusion Criteria:

  • pregnant and breast-feeding women
  • addictive disorders
  • psychic diseases
  • allergy or contra-indication to a drug used in the study
  • presence of postoperative nausea or vomiting
  • administration of glucocorticoid for protecting recurrent laryngeal nerve.
  • protocol not respected
  • protocol refused by the patient
  • intellectual handicap

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ONDANSETRON (OS)
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.
Drug: ondansetron
ondansetron: 4 mg intravenous administration afer the induction of anesthesia.
Active Comparator: DROPERIDOL (DRO)
patients receiving droperidol at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.
Drug: Droperidol
droperidol: 1.25 mg intravenous administration after the induction of anesthesia.
Active Comparator: DEXAMETHASONE (DEXA)
patients receiving dexamethasone at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.
Drug: Dexamethasone
dexametasone: 4 mg intravenous administration after the induction of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"electric nociception threshold" measured by PainMatcher
Time Frame: during 2 hours after thyroidectomy in the postoperative care unit

The PainMatcher is a pain self-assessment device using the electric stimulation of the median nerve. The patient maintains a pressure on an electrode box between the thumb and the index finger, creating a current of increasing intensity. The threshold of pain sensation is obtained when the patient releases his fingers from the electrode box. So whe raise the electric nociceptive threshold showned by the PainMatcher. We realize two measures and consider the second one.

objective measure.
during 2 hours after thyroidectomy in the postoperative care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numeric rating scale score
Time Frame: during 2 hours after thyroidectomy in the postoperative care unit

to evaluate the sensation of pain with a 11 levels going from 0 ( no pain) to 10 ( worst pain imaginable).

subjective measure.
during 2 hours after thyroidectomy in the postoperative care unit
need in rescue analgesia with nefopam in case of numeric rating scale score > 4
Time Frame: during 2 hours after thyroidectomy in the postoperative care unit
during 2 hours after thyroidectomy in the postoperative care unit
presence of postoperative nausea and vomiting
Time Frame: during the 2 hours after thyroidectomy in the postoperative care unit
during the 2 hours after thyroidectomy in the postoperative care unit

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Gilles Lebuffe, MD,PhD, University Hospital of Lille

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

June 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-002701-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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