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

NCT06291363 | Recruiting Phase 4

• 1 other identifier: 2024-3612
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use, Unspecified; Anesthesia; Nociceptive Pain

Keywords

opioid sparing anesthesia; beta blockers; nociception monitoring; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Intra operative remifentanil administration

  Quantity of remifentanil in mcg.kg-1.h-1, administered between the first surgical incision and its discontinuation at wound dressing

  intraoperative (from T0 = incision until Tend = end of dressing)

Secondary Outcomes (10)

• The NOL Index variation before and after orotracheal intubation and first surgical incision

  intraoperative (from T0 = nociceptive stimulation Tend = 3 minutes post stimulation)

• The mean intraoperative blood pressure and heart rate

  intraoperative (from T0 = incision until Tend = end of dressing)

• doses and time weighted of norepinephrine (mg); ephedrine (mg), glycopyrrolate (mg) and atropine (mg)

  intraoperative (from T0 = incision until Tend = end of dressing)

• Total time with NOL value above > 25

  intraoperative (from T0 = incision until Tend = end of dressing)

• The total time and time weighted average of hypotension and/or bradycardia

  intraoperative (from T0 = incision until Tend = end of dressing)

Study Arms (2)

Esmolol

EXPERIMENTAL

In the Esmolol group, intravenous esmolol will be given as a bolus (0.5mg.kg-1) over 5 minutes, and will be started simultaneously to the remifentanil initiation. Once the bolus of esmolol is over, a perfusion of 20 mcg.kg-1.min-1 will be programmed and maintained until the end of the surgery and completion of skin sutures

Drug: Esmolol Hydrochloride

Standard of care

PLACEBO COMPARATOR

In the standard of care group, intravenous saline bolus, equivalent to an esmolol bolus (0.5mg.kg-1) will be given over 5 minutes, and will be started simultaneously to the remifentanil initiation. Once the bolus of saline is over, a saline perfusion equivalent to an esmolol infusion of 20 mcg.kg-1.min-1 will be programmed and maintained until the end of the surgery and completion of skin sutures

Drug: Saline

Interventions

Esmolol Hydrochloride DRUG

Patients in the experimental group will receive esmolol during general anesthesia

Also known as: Brevibloc

Esmolol

Saline DRUG

Patients in the standard of care group will receive saline as placebo during general anesthesia

Also known as: saline serum

Standard of care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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) and left hemicolectomy, of duration time expected under 180 minutes, under general anesthesia
• No allergy to one of the medications used in this study

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal

Montreal East, Quebec, H1T2M4, Canada

RECRUITING

Related Publications (15)

• Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.

  PMID: 16508405 BACKGROUND

• Asouhidou I, Trikoupi A. Esmolol reduces anesthetic requirements thereby facilitating early extubation; a prospective controlled study in patients undergoing intracranial surgery. BMC Anesthesiol. 2015 Nov 28;15:172. doi: 10.1186/s12871-015-0154-1.

  PMID: 26615516 BACKGROUND

• Bergeron C, Brulotte V, Pelen F, Clairoux A, Belanger ME, Issa R, Urbanowicz R, Tanoubi I, Drolet P, Fortier LP, Verdonck O, Fortier A, Espitalier F, Richebe P. Impact of chronic treatment by beta1-adrenergic antagonists on Nociceptive-Level (NOL) index variation after a standardized noxious stimulus under general anesthesia: a cohort study. J Clin Monit Comput. 2022 Feb;36(1):109-120. doi: 10.1007/s10877-020-00626-4. Epub 2021 Jan 4.

  PMID: 33398545 BACKGROUND

• Bohringer C, Astorga C, Liu H. The Benefits of Opioid Free Anesthesia and the Precautions Necessary When Employing It. Transl Perioper Pain Med. 2020;7(1):152-157.

  PMID: 31712783 BACKGROUND

• Celebi N, Cizmeci EA, Canbay O. [Intraoperative esmolol infusion reduces postoperative analgesic consumption and anaesthetic use during septorhinoplasty: a randomized trial]. Rev Bras Anestesiol. 2014 Sep-Oct;64(5):343-9. doi: 10.1016/j.bjan.2013.10.013. Epub 2014 Jun 21. Portuguese.

  PMID: 25168439 BACKGROUND

• Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1.

  PMID: 30983591 BACKGROUND

• Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.

  PMID: 24829420 BACKGROUND

• Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.

  PMID: 29028742 BACKGROUND

• Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.

  PMID: 26154185 BACKGROUND

• Paloheimo MP, Sahanne S, Uutela KH. Autonomic nervous system state: the effect of general anaesthesia and bilateral tonsillectomy after unilateral infiltration of lidocaine. Br J Anaesth. 2010 May;104(5):587-95. doi: 10.1093/bja/aeq065. Epub 2010 Mar 30.

  PMID: 20354006 BACKGROUND

• Renaud-Roy E, Stockle PA, Maximos S, Brulotte V, Sideris L, Dube P, Drolet P, Tanoubi I, Issa R, Verdonck O, Fortier LP, Richebe P. Correlation between incremental remifentanil doses and the Nociception Level (NOL) index response after intraoperative noxious stimuli. Can J Anaesth. 2019 Sep;66(9):1049-1061. doi: 10.1007/s12630-019-01372-1. Epub 2019 Apr 17.

  PMID: 30997633 BACKGROUND

• Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.

  PMID: 29738328 BACKGROUND

• Sabourdin N, Burey J, Tuffet S, Thomin A, Rousseau A, Al-Hawari M, Taconet C, Louvet N, Constant I. Analgesia Nociception Index-Guided Remifentanil versus Standard Care during Propofol Anesthesia: A Randomized Controlled Trial. J Clin Med. 2022 Jan 11;11(2):333. doi: 10.3390/jcm11020333.

  PMID: 35054027 BACKGROUND

• Shahiri TS, Richebe P, Richard-Lalonde M, Gelinas C. Description of the validity of the Analgesia Nociception Index (ANI) and Nociception Level Index (NOL) for nociception assessment in anesthetized patients undergoing surgery: a systematized review. J Clin Monit Comput. 2022 Jun;36(3):623-635. doi: 10.1007/s10877-021-00772-3. Epub 2021 Nov 16.

  PMID: 34783941 BACKGROUND

• Shanthanna H, Ladha KS, Kehlet H, Joshi GP. Perioperative Opioid Administration. Anesthesiology. 2021 Apr 1;134(4):645-659. doi: 10.1097/ALN.0000000000003572.

  PMID: 32991672 BACKGROUND

MeSH Terms

Conditions

Nociceptive Pain

Interventions

esmolol; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pascal Laferrière-Langlois

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Laferrière-Langlois

CONTACT

+1-819-432-5847; pascal.laferriere-langlois@umontreal.ca

Nadia Godin

CONTACT

514-252-3400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done prior to the entrance in the OR, the day of the surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRQS, Assistant Professor, Principal Investigator, Anesthesiologist

Model Details: Two groups of patients randomized into Group "ESMOLOL" for esmolol and group "Standard of Care" for a total of 64 participants.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: April 16, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 4, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)