Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia

Anesthesia Clinical Trial

Official title:

Effect of Dexmedetomidine vs 0.9% Sodium Chloride on Nol-Index Guided Remifentanil Analgesia: a Double-blinded Bicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912740
• Other study ID #: P2018/568
• Status: Completed
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Nociceptive Pain
• Opioid Use
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Drug:
• Dexmedetomidine
Patients in the dexmedetomidine-remifentanil group will receive an infusion of 0.6 mcg/kg in half an hour followed by an infusion of 0.6 mcg/kg/hour.
• sodium chloride
Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate)
• Remifentanil
Both groups will have remifentanil analgesia guided by the Nol-Index

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
Erasme University Hospital	Saint-Pierre University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic	Intraoperative remifentanil consumption	6 hours
Secondary	Propofol Consumption measured as the amount of propofol (mg) administered during the anesthestic	Intraoperative propofol consumption	6 hours
Secondary	Use of vasoactive drugs	Use and amount of vasoactive drugs used (ephedrine/phenylephrine/noradrenaline)	6 hours
Secondary	Use of hypotensive drugs	Use and amount of hypotensive drugs used (nicardipine/esmolol)	6 hours
Secondary	Net fluid balance	Sum of in (infused fluids) and out (net blood loss, diuresis, other losses)	6 hours
Secondary	Time to extubation	Time from end of surgery to extubation of patient	6 hours
Secondary	Number of patients with intraoperative hypotension	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).	6 hours
Secondary	Number of patients with intraoperative hypertension	Intraoperative MAP=100 or surgical need to decrease blood pressure	6 hours
Secondary	Number of patients with hemodynamic instability	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).	6 hours
Secondary	Intraoperative heart rate	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)	6 hours
Secondary	Intraoperative blood pressure	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)	6 hours
Secondary	Intraoperative Nol-Index	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)	6 hours
Secondary	Intraoperative remifentanil target cite concentration	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)	6 hours
Secondary	Postoperative morphine consumption	mg of morphine administered postoperatively	24 hours
Secondary	Number of patients with postoperative opioid-related side effect (composite and individual complications)	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.	72 hours
Secondary	PACU length of stay (LOS)	hours spent at PACU	48 hours
Secondary	Hospital LOS	days spents hospitalized	28 days