The Relationship Of The Surgical Pleth Index Values With Postoperative Pain Score And Analgesia Consumption

NCT05147714 | Completed

• 1 other identifier: 2018/936
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain management has an important role in anesthesia practice. In order to ensure postoperative patient comfort, postoperative rehabilitation should start early and be managed effectively1. It is known that if adequate analgesia is not provided before the patient wakes up, the severity of pain and the total opioid consumption increases. This increased opioid use causes complications such as nausea, vomiting, constipation, increased sleepiness and respiratory depression2. For this reason, the provision of adequate analgesia before the patient is awakened from general anesthesia has an important place in the process. Measurement of pain has different characteristics in patients under sedation or general anesthesia compared to conscious patients. However, since it is not possible for the patient to define pain under general anesthesia, different measurement and evaluation methods are needed. In order to monitor the intraoperative balance between nociception and antinociception, several non-invasive methods with different physiological approaches have been researched and made available for use in the last decade. The aim of these methods is individualize the intraoperative and postoperative opioid dose3. In this context, it has been suggested that the Surgical Pleth Index (SPI) method can be used in the evaluation of the analgesic component of anesthesia.

Conditions

Acute Pain; Analgesia

Keywords

Surgical pleth index; Craniotomy

Outcome Measures

Primary Outcomes (1)

• Acute Postoperative Pain

  Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS). The NRS is an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.

  Postoperative 30 minutes

Interventions

Surgical Pleth Index (SPI) DEVICE

SPI data were recorded at one-minute intervals during the last five minutes (6 times in total) until the entropy value reached 60

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Aged 18 to 65 years
• ASA physical status I-III
• Who received craniotomy and intracranial mass excision

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Mukadder Orhan Sungur, Prof.

  Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Anesthesiology and Reanimation

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 7, 2021
• Study Start: January 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: November 8, 2021
• Last Updated: June 12, 2026

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)