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Completed

NCT Number: NCT02992938

Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

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.

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Key information

Conditions

Hyperalgesia Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Nervous System Diseases Neurologic Manifestations Opioid-Related Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, University of Chile

Santiago, Santiago Metropolitan, 7563215, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetazolamide

Drug

Placebo oral tablet

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia: Randomize Double Blind Clinical Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2016
Registry last updated
Dec 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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