Recruiting PHASE4 Opioid Use, Unspecified

New treatment option for Opioid Use, Unspecified

Official title Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.

ClinicalTrials.gov ID: NCT06291363

What this study is testing

What is Esmolol Hydrochloride?

Esmolol Hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for opioid use, unspecified.

Also referred to as Brevibloc.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

  • Fully consented, American Society of Anesthesiologists Classification Score 1-3 patients from 18yo to 65yo
  • Undergoing laparoscopic surgery associated with sub umbilical mini-laparotomy. Eligible surgeries will be hysterectomy (excluding vaginal approach)...
  • No allergy to one of the medications used in this study

You likely can't join if

  • Contraindication to the use of the study drug (esmolol) is an exclusion criterion :
  • Hypotension
  • Sinus bradycardia
  • Sick sinus syndrome
  • Second and third degree A-V block
  • Pulmonary hypertension
See the full eligibility criteria
Who can join
  • Fully consented, American Society of Anesthesiologists Classification Score 1-3 patients from 18yo to 65yo
  • Undergoing laparoscopic surgery associated with sub umbilical mini-laparotomy. Eligible surgeries will be hysterectomy (excluding vaginal approach) and left hemicolectomy, of duration time expected under 180 minutes...
  • No allergy to one of the medications used in this study
What rules you out
  • Contraindication to the use of the study drug (esmolol) is an exclusion criterion :
  • Hypotension
  • Sinus bradycardia
  • Sick sinus syndrome
  • Second and third degree A-V block
  • Pulmonary hypertension
  • Right ventricular failure secondary to pulmonary hypertension
  • Decompensated heart failure
  • Cardiogenic shock
  • Nontreated pheochromocytoma
  • Known hypersensitivity to esmolol or any of the inactive ingredients of the product
  • Allergy to esmolol or other beta blockers (cross-sensitivity is possible)
  • Renal dysfunction
  • Airway disease such as asthma or chronic obstructive pulmonary disease
  • Thyrotoxicosis
  • Myasthenia gravis
  • Raynaud's disease or peripheral circulatory disorder Other situations leading to exclusion :
  • Severe mental impairment
  • Chronic use of opioids, β-adrenergic receptors antagonists
  • High risk of conversion to laparotomy according to the surgical team (\>25%) Patients will automatically be excluded after recruitment if they withdraw their consent, or if laparoscopy is converted to laparotomy.

The study team makes the final eligibility decision.

Where it's taking place

  • Montreal East, Quebec, Canada

Compensation & support

A stipend or compensation may be offered.

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Montreal East, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.