Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

Phase 4

Completed

• Conditions: Hyperalgesia; Opioid-Related Disorders
• Interventions: Drug: Placebo Oral Tablet; Drug: Acetazolamide

• Registration Number: NCT02992938
• Lead Sponsor: University of Chile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-14
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-28
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	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
Acetazolamide	Acetazolamide	250 mg VO of acetazolamide will be administered the day of the surgery 2 hours before anesthesia induction

Primary Outcome Measures

Name	Time	Method
Change in the mechanical pain threshold in an area distant to the site of the injury	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 Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine, University of Chile; 🇨🇱 Santiago, Metropolitana, Chile