Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992938
• Other study ID #: 803/16
• Status: Completed
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: September 28, 2018

Study information

• Verified date: December 2018
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperalgesia
• Opioid-Related Disorders

Intervention

Drug:
• Acetazolamide

• Placebo Oral Tablet

Locations

Country	Name	City	State
Chile	Faculty of Medicine, University of Chile	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (4)

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. — View Citation

Echevarría G, Elgueta F, Fierro C, Bugedo D, Faba G, Iñiguez-Cuadra R, Muñoz HR, Cortínez 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12-18 hours after the end of the surgery
Secondary	Change in the mechanical pain threshold in an area distant to the site of the injury		2 hours after the end of the surgery
Secondary	Postoperative pain	A visual analogue scale (VAS; 0, no pain; 100, worst poss- ible pain) will be used to assess pain	The first postoperative day
Secondary	Morphine consumption	Morphine consumption with a patient controlled analgesia (PCA) in mg	The first postoperative day