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Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

U

University of Chile

Status and phase

Completed
Phase 4

Conditions

Hyperalgesia
Opioid-Related Disorders

Treatments

Drug: Placebo Oral Tablet
Drug: Acetazolamide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

Acetazolamide
Experimental group
Description:
250 mg VO of acetazolamide will be administered the day of the surgery 2 hours before anesthesia induction
Treatment:
Drug: Acetazolamide
Placebo
Placebo Comparator group
Description:
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
Treatment:
Drug: Placebo Oral Tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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