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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01679093
First received: August 31, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Interaction Between Antiemetic Drugs and Paracetamol
Drug: ondansetron
Drug: Droperidol
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia.

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • "electric nociception threshold" measured by PainMatcher [ Time Frame: during 2 hours after thyroidectomy in the postoperative care unit ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • numeric rating scale score [ Time Frame: during 2 hours after thyroidectomy in the postoperative care unit ] [ Designated as safety issue: Yes ]

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

    subjective measure.


  • 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 ] [ Designated as safety issue: Yes ]
  • presence of postoperative nausea and vomiting [ Time Frame: during the 2 hours after thyroidectomy in the postoperative care unit ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ONDANSETRON (OS)
patients receiving ondansetron at the begining 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 intraveinous administration afer the induction of anesthesia.
Active Comparator: DROPERIDOL (DRO)
patients receiving droperidol at the begining of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.
Drug: Droperidol
droperidol: 1.25 mg intraveinous administration after the induction of anesthesia.
Active Comparator: DEXAMETHASONE (DEXA)
patients receiving dexamethasone at the begining of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.
Drug: Dexamethasone
dexametasone: 4 mg intraveinous administration after the induction of anesthesia.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 recurent laryngeal nerve.
  • protocol not respected
  • protocol refused by the patient
  • intellectual handicap
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679093

Locations
France
Hospital and university center
Lille, France, 59000
Sponsors and Collaborators
University Hospital, Lille
  More Information

Publications:

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01679093     History of Changes
Other Study ID Numbers: 2008-002701-40
Study First Received: August 31, 2012
Last Updated: August 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
postoperative analgesia
paracetamol
5-HT3 antagonist
ondansetron
PainMatcher

Additional relevant MeSH terms:
Acetaminophen
Dexamethasone
Droperidol
Ondansetron
Antiemetics
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Autonomic Agents
Gastrointestinal Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Antipsychotic Agents

ClinicalTrials.gov processed this record on April 23, 2014