Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia

NCT ID: NCT03912740

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2019-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Remifentanil Analgesia

Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride

Group Type: ACTIVE_COMPARATOR

sodium chloride

Intervention Type: DRUG

Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate)

Remifentanil

Intervention Type: DRUG

Both groups will have remifentanil analgesia guided by the Nol-Index

Remifentanil and Dexmedetomidine Analgesia

Continuous intraoperative analgesia with remifenanil + dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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.

Remifentanil

Intervention Type: DRUG

Both groups will have remifentanil analgesia guided by the Nol-Index

Interventions

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.

Intervention Type: DRUG

sodium chloride

Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate)

Intervention Type: DRUG

Remifentanil

Both groups will have remifentanil analgesia guided by the Nol-Index

Intervention Type: DRUG

Other Intervention Names

Dexdor; normal saline 0.9%; Ultiva

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint-Pierre University Hospital

OTHER

Sponsor Role: collaborator

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Coeckelenbergh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles

Locations

Erasme University Hospital

Brussels, , Belgium

Countries

Belgium

References

Coeckelenbergh S, Doria S, Patricio D, Perrin L, Engelman E, Rodriguez A, Di Marco L, Van Obbergh L, Estebe JP, Barvais L, Kapessidou P. Effect of dexmedetomidine on Nociception Level Index-guided remifentanil antinociception: A randomised controlled trial. Eur J Anaesthesiol. 2021 May 1;38(5):524-533. doi: 10.1097/EJA.0000000000001402.

Reference Type: DERIVED

PMID: 33259449 (View on PubMed)

Other Identifiers

P2018/568

Identifier Type: -

Identifier Source: org_study_id