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Trial record 20 of 705 for:    region | Chile

Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

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ClinicalTrials.gov Identifier: NCT02992938
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Rodrigo Gutiérrez, University of Chile

Brief Summary:

Remifentanil is a potent opioid widely used during the administration of general anesthesia. There is a lot of evidence that suggest that the used of remifentanil is associated with the development of hyperalgesia (a reduction of nociceptive thresholds). However, the mechanism of this hyperalgesia is not fully understood.

Recently, it was demonstrated that the disruption of the Cl- homeostasis could be involved. Interestingly, this was prevented in a murine model with the administration of Acetazolamide, a carbonic anhydrase inhibitor. In our clinical trial we will try to determine if the preoperative administration of acetazolamide could prevent the hyperalgesia induced by remifentanil in patients scheduled for thyroidectomy with general anesthesia.


Condition or disease Intervention/treatment Phase
Hyperalgesia Opioid-Related Disorders Drug: Acetazolamide Drug: Placebo Oral Tablet Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia: Randomize Double Blind Clinical Trial
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetazolamide
250 mg VO of acetazolamide will be administered the day of the surgery 2 hours before anesthesia induction
Drug: Acetazolamide
Placebo Comparator: Placebo
An oral tablet without active principle acetazolamide but with the same physical characteristics will be administered the day of the surgery 2 hours before anesthesia induction
Drug: Placebo Oral Tablet



Primary Outcome Measures :
  1. Change in the mechanical pain threshold in an area distant to the site of the injury [ Time Frame: 12-18 hours after the end of the surgery ]
    The threshold will be determine using von Frey monofilaments before the surgery and will be compared 12-18 hours after the end of the surgery


Secondary Outcome Measures :
  1. Change in the mechanical pain threshold in an area distant to the site of the injury [ Time Frame: 2 hours after the end of the surgery ]
  2. Postoperative pain [ Time Frame: The first postoperative day ]
    A visual analogue scale (VAS; 0, no pain; 100, worst poss- ible pain) will be used to assess pain

  3. Morphine consumption [ Time Frame: The first postoperative day ]
    Morphine consumption with a patient controlled analgesia (PCA) in mg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for thyroidectomy with general anesthesia in the University of Chile Clinical Hospital

Exclusion Criteria:

  • Patients ASA III y IV
  • Chronic pain history
  • Drug and alcohol abuse
  • Chronic use of opioid and sedatives
  • Neuropsychiatric illness
  • NSAID and other analgesics used the 48 hours previous to the surgery
  • CMI > 30

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992938


Contacts
Contact: Rodrigo Gutierrez, MD +56995993665 rggutierrez1@gmail.com
Contact: Antonello Penna, MD PhD +56956756623 apennas@gmail.com

Locations
Chile
Faculty of Medicine, University of Chile Recruiting
Santiago, Metropolitana, Chile, 7563215
Contact: Rodrigo Gutierrez, MD    +56995993665    rggutierrez1@gmail.com   
Sponsors and Collaborators
University of Chile
Investigators
Principal Investigator: Rodrigo Gutierrez, MD Anesthesia Department, University of Chile
Principal Investigator: Antonello Penna, MD PhD Anesthesia Department, University of Chile

Publications of Results:
Responsible Party: Rodrigo Gutiérrez, MD, University of Chile
ClinicalTrials.gov Identifier: NCT02992938     History of Changes
Other Study ID Numbers: 803/16
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rodrigo Gutiérrez, University of Chile:
Opioid hyperalgesia
Acetazolamide
Remifentanil

Additional relevant MeSH terms:
Hyperalgesia
Opioid-Related Disorders
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Remifentanil
Acetazolamide
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents