Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

Sponsor

University of Chile (Other)

Overall Status

Completed

CT.gov ID

NCT02992938

Collaborator

(none)

Enrollment

Location

Arms

21.9

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperalgesia Opioid-Related Disorders	Drug: Acetazolamide Drug: Placebo Oral Tablet	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Sep 28, 2018

Actual Study Completion Date :

Sep 28, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Acetazolamide

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

Drug: Acetazolamide

Placebo Comparator: 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

Drug: Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, University of Chile	Santiago	Metropolitana	Chile	7563215

Sponsors and Collaborators

University of Chile

Investigators

Principal Investigator: Rodrigo Gutierrez, MD, Anesthesia Department, University of Chile
Principal Investigator: Antonello Penna, MD PhD, Anesthesia Department, University of Chile