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Comparison of Opioid Consumption During TCI Guided by NOL Index or Standard Care Undergoing Intracranial Tumor Surgery

NCT05732896 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-06-22

No results posted yet for this study

Summary

In this prospective, randomized controlled study, we hypothesized that nociception level index monitoring reduced opioid administration during surgery. The secondary goals are to compare the total dose hypnotic drugs, as well as hemodynamic parameters, and to investigate the relationship between changes in the NOL index and HR change following severe noxious stimuli during effect site TCI of propofol and remifentanil in patients undergoing intracranial tumor surgery who are monitored using either standard monitors or the NOL monitor additionally.

Conditions

  • Target Controlled Infusion
  • Intracranial Neoplasm
  • Opioid
  • Nociceptive Pain
  • Anesthesia

Interventions

DEVICE

Nociception Leve Indeks

During TIVA-TCI, propofol (Schnider) effect site concentration (Ce) was titrated to BIS score between 40-60 and remifentanil (Minto) Ce to standard hemodynamic parameters in the control group and NOL index value between 10-25 in the study group.

Sponsors & Collaborators

  • Uludag University

    collaborator OTHER

  • Turkish Society of Anesthesiology and Reanimation

    lead OTHER

Principal Investigators

  • Hulya Bilgin · Bursa Uludağ University Faculty of Medicine Department of Anesthesiology and Reanimation

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2022-10-02
Completion
2023-08-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05732896 on ClinicalTrials.gov