NOL-Guided vs Conventional Intraoperative Opioid Infusion on Outcomes in Geriatric Patients

NCT07075003 | Not Yet Recruiting

• 1 other identifier: sabitagaoglu
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the effects of conventional methods and goal-directed therapy guided by pain monitoring on total remifentanil dosage, wake-up time, and complications in geriatric patients undergoing lumbar stabilization surgery.

Conditions

Pain; Opioid Use; Geriatric Anesthesia

Outcome Measures

Primary Outcomes (1)

• Total dose

  Total dose of remifentanil used in operation

  operation duration

Secondary Outcomes (2)

• postoperative pain

  postoperative 10th, 20th, and 30th minutes, 1, 3, 6, and 24 hours

• nausea and vomiting

  postoperative 10th, 20th, and 30th minutes, 1, 3, 6, and 24 hours

Study Arms (2)

Conservative

Our clinic's standard anesthesia induction and maintenance method will be applied to all patients. Patients will receive standard monitoring including peripheral oxygen saturation, non-invasive blood pressure, ECG, and anesthesia depth. All patients will receive intravenous 2-2.5 mg/kg propofol under Sedline guidance, and remifentanil via target-controlled infusion at an effect-site concentration of 4 ng/ml. After anesthesia depth falls below 50, 0.6 mg/kg rocuronium will be administered. Maintenance anesthesia will be with 1-2% sevoflurane in 40/60% oxygen/air mixture at 2 L flow.Remifentanil is administered as a continuous infusion in conservative approach;dosage adjustments are made based on heart rate and blood pressure changes to estimate pain levels.

Nociceptive level

Our clinic's standard anesthesia induction and maintenance method will be applied to all patients. Patients will receive standard monitoring including peripheral oxygen saturation, non-invasive blood pressure, ECG, and anesthesia depth. All patients will receive intravenous 2-2.5 mg/kg propofol under Sedline guidance, and remifentanil via target-controlled infusion at an effect-site concentration of 4 ng/ml. After anesthesia depth falls below 50, 0.6 mg/kg rocuronium will be administered. Maintenance anesthesia will be with 1-2% sevoflurane in 40/60% oxygen/air mixture at 2 L flow.Remifentanil is administered as a continuous infusion by using Nociceptive level guidance

Device: nociceptive level

Interventions

nociceptive level DEVICE

remifentanil infusion dose adjustment according to the changes of nociceptive level

Nociceptive level

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 80 geriatric patients undergoing lumbar stabilization surgery

You may qualify if:

• Patients undergoing lumbar stabilization surgery

You may not qualify if:

• Chronic opioid use
• Severe congestive heart failıure
• Severe arrhythmia
• Uncontrolled hypertension

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Related Publications (3)

• Gazelka HM, Leal JC, Lapid MI, Rummans TA. Opioids in Older Adults: Indications, Prescribing, Complications, and Alternative Therapies for Primary Care. Mayo Clin Proc. 2020 Apr;95(4):793-800. doi: 10.1016/j.mayocp.2020.02.002.

  PMID: 32247352 BACKGROUND

• Hwang W, Lee J, Park J, Joo J. Dexmedetomidine versus remifentanil in postoperative pain control after spinal surgery: a randomized controlled study. BMC Anesthesiol. 2015 Feb 24;15:21. doi: 10.1186/s12871-015-0004-1. eCollection 2015.

  PMID: 25750586 BACKGROUND

• Mercadante S. Influence of aging on opioid dosing for perioperative pain management: a focus on pharmacokinetics. J Anesth Analg Crit Care. 2024 Aug 1;4(1):51. doi: 10.1186/s44158-024-00182-2.

  PMID: 39085914 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Süheyla Abitağaoğlu

  UNIVERSİTY OF HEALTH SCIENCES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Süheyla Abitağaoğlu

CONTACT

05325267656; suheylaatay81@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 20, 2025
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07