NOL study

JRCT ID: jRCTs072240066

Registered date:02/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Spine
• Date of first enrollment: 02/10/2024
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Anesthesia management using Nociception level index (NOL)

Outcome(s)

• Primary Outcome: Intraoperative remifentanil dose

Secondary Outcome

Events during anesthesia
1)Vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine)
2)Hypotension: mean arterial pressure < 55 mmHg (severe hypotension) or mean arterial pressure < 60 mmHg (moderate hypotension)
3)Hypertension: systolic blood pressure > 140 mmHg
4)Bradycardia: heart rate < 45 min-1
5)Tachycardia: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 79age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamaura Ken
• Secondary Sponsor: TERUMO CORPORATION