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Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

Primary Purpose

Hyperalgesia, Opioid-Related Disorders

Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Acetazolamide
Placebo Oral Tablet
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperalgesia focused on measuring Opioid hyperalgesia, Acetazolamide, Remifentanil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Medicine, University of Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetazolamide

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in the mechanical pain threshold in an area distant to the site of the injury
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

Change in the mechanical pain threshold in an area distant to the site of the injury
Postoperative pain
A visual analogue scale (VAS; 0, no pain; 100, worst poss- ible pain) will be used to assess pain
Morphine consumption
Morphine consumption with a patient controlled analgesia (PCA) in mg

Full Information

First Posted
December 11, 2016
Last Updated
December 28, 2018
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT02992938
Brief Title
Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia
Official Title
Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia: Randomize Double Blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia, Opioid-Related Disorders
Keywords
Opioid hyperalgesia, Acetazolamide, Remifentanil

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Experimental
Arm Description
250 mg VO of acetazolamide will be administered the day of the surgery 2 hours before anesthesia induction
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Change in the mechanical pain threshold in an area distant to the site of the injury
Description
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
Time Frame
12-18 hours after the end of the surgery
Secondary Outcome Measure Information:
Title
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
Title
Postoperative pain
Description
A visual analogue scale (VAS; 0, no pain; 100, worst poss- ible pain) will be used to assess pain
Time Frame
The first postoperative day
Title
Morphine consumption
Description
Morphine consumption with a patient controlled analgesia (PCA) in mg
Time Frame
The first postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Gutierrez, MD
Organizational Affiliation
Anesthesia Department, University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonello Penna, MD PhD
Organizational Affiliation
Anesthesia Department, University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, University of Chile
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7563215
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23292683
Citation
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.
Results Reference
result
PubMed Identifier
21965050
Citation
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.
Results Reference
result
PubMed Identifier
14581110
Citation
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.
Results Reference
result
PubMed Identifier
15983467
Citation
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.
Results Reference
result

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Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

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