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New monitor may predict Post-Surgery pain before patients wake up

NCT ID NCT05147714

Knowledge-focused Sponsor: Istanbul University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a tool called the Surgical Pleth Index (SPI), which measures stress during surgery, can predict how much pain a person will feel after waking up from a brain operation. 52 adults having craniotomy were monitored, and their pain scores and painkiller use after surgery were recorded. The goal was to see if SPI could help doctors give better pain relief and reduce the need for strong opioids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

52 people

The number who actually took part.

Started

Jan 2019

Finished

Nov 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients aged 18 to 65 years with ASA physical status I-III who received craniotomy and intracranial mass excision in the ITF Neurosurgery Clinic were enrolled in the study after providing written informed consent

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18 to 65 years * ASA physical status I-III * Who received craniotomy and intracranial mass excision Exclusion Criteria: * Diagnosed diabetic neuropathy * Using pacemaker * Needing vasoactive agent during the observation * Using ketamine * Using agents such as beta-blockers, beta-agonists, sympatholytic agents, atropine, neostigmine that will affect the sympatho-vagal balance during the observation period * The patients who could not provide sufficient cooperation for scoring were not included in the study.

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Conditions

The condition(s) this trial relates to.

Acute Pain agnosia pain agnosia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pain Analgesia

Contacts and locations

Locations

  • Istanbul University

    Istanbul, 34093, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.