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Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

NCT ID: NCT02992938

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperalgesia Opioid-Related Disorders

Keywords

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Opioid hyperalgesia Acetazolamide Remifentanil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acetazolamide

250 mg VO of acetazolamide will be administered the day of the surgery 2 hours before anesthesia induction

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Interventions

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Acetazolamide

Intervention Type DRUG

Placebo Oral Tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Gutiérrez

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo Gutierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia Department, University of Chile

Antonello Penna, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia Department, University of Chile

Locations

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Faculty of Medicine, University of Chile

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

References

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Ferrini F, Trang T, Mattioli TA, Laffray S, Del'Guidice T, Lorenzo LE, Castonguay A, Doyon N, Zhang W, Godin AG, Mohr D, Beggs S, Vandal K, Beaulieu JM, Cahill CM, Salter MW, De Koninck Y. Morphine hyperalgesia gated through microglia-mediated disruption of neuronal Cl(-) homeostasis. Nat Neurosci. 2013 Feb;16(2):183-92. doi: 10.1038/nn.3295. Epub 2013 Jan 6.

Reference Type RESULT
PMID: 23292683 (View on PubMed)

Echevarria G, Elgueta F, Fierro C, Bugedo D, Faba G, Iniguez-Cuadra R, Munoz HR, Cortinez LI. Nitrous oxide (N(2)O) reduces postoperative opioid-induced hyperalgesia after remifentanil-propofol anaesthesia in humans. Br J Anaesth. 2011 Dec;107(6):959-65. doi: 10.1093/bja/aer323. Epub 2011 Sep 28.

Reference Type RESULT
PMID: 21965050 (View on PubMed)

Angst MS, Koppert W, Pahl I, Clark DJ, Schmelz M. Short-term infusion of the mu-opioid agonist remifentanil in humans causes hyperalgesia during withdrawal. Pain. 2003 Nov;106(1-2):49-57. doi: 10.1016/s0304-3959(03)00276-8.

Reference Type RESULT
PMID: 14581110 (View on PubMed)

Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.

Reference Type RESULT
PMID: 15983467 (View on PubMed)

Other Identifiers

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803/16

Identifier Type: -

Identifier Source: org_study_id