NOL study (NOL study)

Recruiting

• Conditions: Spine

• Registration Number: jRCTs072240066

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-02
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

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

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Intraoperative remifentanil dose

Secondary Outcome Measures

Name	Time	Method
Vasoactive medication		ephedrine, phenylephrine, norepinephrine, atropine
Hypotension		mean arterial pressure < 55 mmHg (severe hypotension) or mean arterial pressure < 60 mmHg (moderate hypotension)
Hypertension		systolic blood pressure > 140 mmHg
Bradycardia		heart rate < 45 min-1
Tachycardia		heart rate > 90 min-1
Stress hormone levels		cortisol, ACTH (before surgery and at time of leaving operation room)
Total dose of postoperative analgesics	24 hours	NSAIDs, etc.
Serum creatinine and troponin levels		before surgery and after the postoperative day 1