Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Hypotension
Sinus bradycardia
Sick sinus syndrome
Second and third degree A-V block
Trial design
Design model
Parallel
Treatments tested in this trial
Esmolol Hydrochloride
DrugPatients in the experimental group will receive esmolol during general anesthesia
Saline
DrugPatients in the standard of care group will receive saline as placebo during general anesthesia
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: EsmololExperimental treatment 1 intervention
Group B: Standard of carePlacebo comparator 1 intervention
Trial outcomes
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
Time frame
intraoperative (from T0 = incision until Tend = end of dressing)Secondary outcomes
1
The NOL Index variation before and after orotracheal intubation and first surgical incision
The NOL Index variation before and after orotracheal intubation and first surgical incision
Time frame
intraoperative (from T0 = nociceptive stimulation Tend = 3 minutes post stimulation)2
The mean intraoperative blood pressure and heart rate
The mean intraoperative blood pressure and heart rate during surgery
Time frame
intraoperative (from T0 = incision until Tend = end of dressing)3
doses and time weighted of norepinephrine (mg); ephedrine (mg), glycopyrrolate (mg) and atropine (mg)
doses and time weighted average of norepinephrine (mg); ephedrine (mg), glycopyrrolate (mg) and atropine (mg)
Time frame
intraoperative (from T0 = incision until Tend = end of dressing)4
Total time with NOL value above > 25
Total time and time weighted average with NOL value above \> 25
Time frame
intraoperative (from T0 = incision until Tend = end of dressing)Sponsors and contacts
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Source ClinicalTrials.gov