Analgesia Nociception Index (ANI) in Intracranial Surgical Anesthesia

NCT06752824 | Completed FDA Device

• 1 other identifier: TÜTF-BAEK 2020/406
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

In our study, 75 patients aged 18-80 years, classified as ASA I-II risk groups, who underwent intracranial surgery performed by the Department of Neurosurgery at Trakya University Faculty of Medicine Hospital, were included. After the patients were positioned on the neurosurgical operating table, heart rate, systolic blood pressure, diastolic blood pressure, peripheral oxygen saturation, and entropy values were measured in all cases. Baseline values were recorded for patients who underwent ANI (Analgesia Nociception Index) monitoring. In both groups, entropy values were targeted to remain within the range of 40-60. In the ANI group, ANI values were maintained between 50-70. Patients were divided into two groups based on the intraoperative monitoring method applied: the ANI group (n=38) and the control group (n=37). All patients underwent entropy monitoring, while ANI monitoring was exclusively used in the ANI group for pain management. In the ANI group, remifentanil infusion adjustments were made to keep ANI values within the 50-70 range. This study aimed to compare perioperative opioid consumption, postoperative pain, and recovery from anesthesia in patients undergoing intracranial surgery who received general anesthesia and analgesia management guided by either entropy monitoring alone or a combination of entropy and ANI monitoring.

Conditions

Pain, Postoperative; Analgesia; Supratentorial Brain Tumor; Infratentorial Neoplasms; Pituitary Neoplasms; Intraoperative Monitoring; Pain Monitoring

Keywords

INTRACRANIAL SURGERY; ENTROPY; ANI

Outcome Measures

Primary Outcomes (1)

• INTRAOPERATIVE OPIOID USE

  Lower dose opioid use during surgery is associated with more favorable outcomes in terms of postoperative pain and recovery scores.

  during the surgery/procedure

Study Arms (2)

ANI GROUP

ANI MONITORING

Device: ANALGESIA NOCICEPTION INDEX MONITORING

CONTROL GROUP

STANDARD MONITORING

Interventions

ANALGESIA NOCICEPTION INDEX MONITORING DEVICE

INTRACRANIAL SURGERY

Also known as: ANI

ANI GROUP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Seventy-five patients in ASA I-II risk group aged 18-80 who will undergo intracranial surgery by Brain and Nerve Surgery at Trakya University Faculty of Medicine Hospital will be included in the study.

You may qualify if:

• ASA I-II patients
• Patients between the ages of 18-80
• patients undergoing intracranial surgery

You may not qualify if:

• major comorbid diseases,
• patients using beta adrenergic blockers, clonidine,
• patients with pacemakers or significant arrhythmias (e.g. atrial fibrillation),
• patients using medications that affect sinus rhythm (atropine, ephedrine, glycopyrrolate),
• patients with chronic pain and cerebrovascular diseases,
• patients who will undergo planned postoperative ventilation,
• patients with chronic pain due to opioid medications, and patients with opioid addiction

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya Üniversitesi Tip Fakültesi

Edirne, Merkez, 22100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Infratentorial Neoplasms; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• SEVTAP HEKİMOĞLU ŞAHİN

  Trakya University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESEARCH ASSISTANT DOCTOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 31, 2024
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

TU (1)