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The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption

ConditionsDexmedetomidineTotal Intravenous AnesthesiaRemifentanil ConsumptionRemifentanilLaparoscopic Abdominal Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCiusss de L'Est de l'Île de Montréal

About this trial

Opioids analgesic are the gold standard for intraoperative pain management. Their short- and long-term adverse effect motivate anesthesiologists to explore opioid sparing strategies. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. This new randomized controlled trial (RCT) will answer the question whether an intraoperative dexmedetomidine infusion compared to placebo has a clinically significant impact on intraoperative remifentanil consumption during a laparoscopic abdominal elective surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA 1-3

Laparascopic surgery (including general surgery, gynecology, urology) a small abdominal incision (less than 5 cm) will be tolerated.

Disqualifiers

Patient refusal

Chronic use of opioids

Allergy to medication used in the trial

Pregnant or breastfeeding women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Intravenous dexmedetomidine will be given as a bolus (0.5 μg.kg-1) over 10 minutes. A perfusion of 0.5 mcg.kg-1.h-1 of dexmedetomidine will be programmed and maintained up until the pneumoperitoneum is deflated or up until a total dose of 2.5μg.kg-1 has been administered.

  • Placebo

    Drug

    Saline will be used instead of dexmedetomidine

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: DexmedetomidineActive comparator 1 intervention
Group B: Placebo - Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Remifentanil consumption expressed in mcg.kg-1.h-1

Compare remifentanil consumption when using an intraoperative dexmedetomidine infusion (bolus of 0.5mcg.kg-1, than infusion of 0.5 mcg.kg-1.h-1, with a maximum dose of 2.5 mcg.kg-1) versus placebo (normal saline)

Time frame
From induction of anesthesia to end of surgery

Secondary outcomes

1

Total intraoperative propofol consumption (mg.kg-1.h-1)

Compare the total intraoperative propofol consumption during anesthesia, to maintien BIS values between 40-60

Time frame
From induction of anesthesia to end of surgery
2

Mean intraoperative blood pressure

Compare intraoperative blood pressure in both groups (mmHg)

Time frame
From induction of anesthesia to end of surgery
3

Number of intraoperative episodes of high/low blood pressure

Compare episodes of high blood pressure (defined as + 20% of patient's baseline) ans episodes of low blood pressure (defined as - 20% of patient's baseline) between both groups

Time frame
From induction of anesthesia to end of surgery
4

Number of episodes of intraoperative tachy-/bradycardia

Compare episodes of tachycardia (defined as \> 100 bpm) and episodes of bradycardia (defined as \< 45 bpm) between both groups

Time frame
From induction of anesthesia to end of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ciusss de L'Est de l'Île de Montréal

Lead sponsor

Maisonneuve-Rosemont Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: