Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia

Not Applicable

Completed

• Conditions: Anesthesia; Perioperative/Postoperative Complications; Nociceptive Pain; Opioid Use
• Interventions: Drug: sodium chloride; Drug: Dexmedetomidine; Drug: Remifentanil

• Registration Number: NCT03912740
• Lead Sponsor: Erasme University Hospital

Brief Summary

Background:

Analgesia remains to this day a challenge for anesthesiologists. Dexmedetomidine, a potent central alpha-2 agonist, has been shown to have analgesic and opioid sparing effects. The classic analgesic strategy focuses on opioid administration guided by estimated time of elimination and hemodynamic response (increase in blood pressure and heart rate). This technique is not sensitive and forces the anesthesiologist to be one step behind nociception, the patient's unconscious response to pain.

PMD-200 (Medasense, Israel) displays the Nociceptive level (NOL)-Index as marker of nociception. The NOL-Index ranges from 0 (no nociception) to 100 (intense nociception) and the recommended analgesic range during surgery is from 10 to 25 (Medasense recommendations).

The goal of this study is to compare two analgesia strategies guided by the NOL Index (range 10-25) using either remifentanil TCI (target controlled infusion) alone or remifentanil TCI associated with a continuous dexmedetomidine infusion.

Methods:

A total of 100 patients will be included and informed consent will be acquired. This bi-center study will take place at Erasme University Hospital (primary center) and Saint-Pierre University Hospital. Patients will be randomized into either two groups: remifentanil and placebo versus remifentanil and dexmedetomidine. Both groups will be monitored using the PMD-200 that will guide the analgesic therapy strategy. Investigators and patients will be blinded to dexmedetomidine and placebo administration. The primary outcome will be intraoperative remifentanil consumption. Secondary outcomes will include postoperative opioid administration, opioid associated complications, hemodynamics, and hospital length of stay.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-04-10
• Study Start: 2019-04-11
• Study First Posted: 2019-04-11
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• American Society of Anesthesiologists (ASA) grades 1-2 undergoing scheduled stomatological, cervical, and thyroid surgery anticipated to last at least two hours

Exclusion Criteria

• ASA score >2
• Preoperative organ dysfunction
• Patients with non-regular cardiac rhythm
• Implanted pacemakers
• Emergent surgery
• Pregnancy or lactation
• Allergy or intolerance to any of the study drugs
• Participation in another interventional study
• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil Analgesia	Remifentanil	Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride
Remifentanil Analgesia	sodium chloride	Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride
Remifentanil and Dexmedetomidine Analgesia	Dexmedetomidine	Continuous intraoperative analgesia with remifenanil + dexmedetomidine
Remifentanil and Dexmedetomidine Analgesia	Remifentanil	Continuous intraoperative analgesia with remifenanil + dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic	6 hours	Intraoperative remifentanil consumption

Secondary Outcome Measures

Name	Time	Method
Intraoperative Nol-Index	6 hours	Measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia)
PACU length of stay (LOS)	48 hours	hours spent at PACU
Propofol Consumption measured as the amount of propofol (mg) administered during the anesthestic	6 hours	Intraoperative propofol consumption
Time to extubation	6 hours	Time from end of surgery to extubation of patient
Number of patients with intraoperative hypotension	6 hours	Intraoperative MAP (mean arterial pressure) \<65 mmHg\*; * Patients that have chronic hypertension or that are 65 years of age or older will have a MAP threshold of 75mmHg (and not 65mmHg).
Postoperative morphine consumption	24 hours	mg of morphine administered postoperatively
Number of patients with postoperative opioid-related side effect (composite and individual complications)	72 hours	Post-operative nausea or vomiting within the first 24 h, postoperative hypoxemia (need within 24h postop to have supplemental oxygen (to maintain sat \>94%), and pruritus.
Hospital LOS	28 days	days spents hospitalized
Net fluid balance	6 hours	Sum of in (infused fluids) and out (net blood loss, diuresis, other losses)
Use of hypotensive drugs	6 hours	Use and amount of hypotensive drugs used (nicardipine/esmolol)
Intraoperative heart rate	6 hours	Measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia)
Use of vasoactive drugs	6 hours	Use and amount of vasoactive drugs used (ephedrine/phenylephrine/noradrenaline)
Intraoperative blood pressure	6 hours	Measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia)
Intraoperative remifentanil target cite concentration	6 hours	Measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia)
Number of patients with intraoperative hypertension	6 hours	Intraoperative MAP≥100 or surgical need to decrease blood pressure
Number of patients with hemodynamic instability	6 hours	MAP\<65 mmHg\*, HR\<45, MAP≥100, HR\>90; \* Patients that have chronic hypertension or that are 65 years of age or older will have a MAP threshold of 75mmHg for hypotension (and not 65mmHg).

Trial Locations

Locations (1)

Erasme University Hospital; 🇧🇪 Bruxelles, Belgium