NOL study

Non-randomized trial to evaluate the efficacy and safety of the Nociception Level Index in supine surgery patients - NOL study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs072240066

Enrollment

110

Registered

2024-10-02

Start date

2024-10-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Spine

Interventions

Anesthesia management using Nociception level index (NOL)

Nociception level index

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Participants undergoing posterior spinal fusion surgery (open surgery) 2)Participants who have given their own voluntary written consent (for retrospective study participants, those who can opt out of the study) 3)Participants aged 16 to 79 years at the time of consent 4)Participants weighing 30kg or more 5)Participants with ASA-PS of I to III before the start of the study

Exclusion criteria

Exclusion criteria: 1)Participants with arrhythmia 2)Participants with a history of drug hypersensitivity (propofol, remifentanil, and/or fentanyl) 3)Participants taking steroids 4)Endoscopic surgery, anterior cervical discectomy and fusion 5)Participants who the principal investigator judges inappropriate for inclusion in the study

Design outcomes

Primary

Measure	Time frame
Intraoperative remifentanil dose	—

Secondary

Measure	Time frame
Events during anesthesia 1)Vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) 2)Hypotension: mean arterial pressure 140 mmHg 4)Bradycardia: heart rate 90 min-1 Intraoperative information 1)Fentanyl consumption 2)Propofol consumption 3)Stress hormone (cortisol, ACTH) levels (before surgery and at time of leaving operation room) 4)Nociception level index Post-operative information 1)Post-operative pain score (NRS) (24 hours) 2)Total dose of postoperative fentanyl (24 hours) 3)Total dose of postoperative analgesics (NSAIDs, etc.) (24 hours) 4)Serum creatinine and troponin levels (before surgery and after the postoperative day 1)	—

Measure

Time frame

Events during anesthesia 1)Vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) 2)Hypotension: mean arterial pressure 140 mmHg 4)Bradycardia: heart rate 90 min-1 Intraoperative information 1)Fentanyl consumption 2)Propofol consumption 3)Stress hormone (cortisol, ACTH) levels (before surgery and at time of leaving operation room) 4)Nociception level index Post-operative information 1)Post-operative pain score (NRS) (24 hours) 2)Total dose of postoperative fentanyl (24 hours) 3)Total dose of postoperative analgesics (NSAIDs, etc.) (24 hours) 4)Serum creatinine and troponin levels (before surgery and after the postoperative day 1)

—

Contacts

Public ContactMasako Asada

Kyushu University Hospital

asada.masako.105@m.kyushu-u.ac.jp+81-92-642-5714

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026