CompletedNot Applicable

Analgesia Nociception Index (ANI) in Intracranial Surgical Anesthesia

Turkey (Türkiye)75 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA I-II patients * Patients between the ages of 18-80 * patients undergoing intracranial surgery Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

INTRAOPERATIVE OPIOID USE

Timeframe: during the surgery/procedure

Trial details

NCT IDNCT06752824

SponsorTrakya University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Pain, Postoperative trials