Acute PainNCT05147714
The Relationship Of The Surgical Pleth Index Values With Postoperative Pain Score And Analgesia Consumption
An observational study of Acute Pain and Analgesia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Analgesia
- What is being tested?
- Surgical Pleth Index (SPI)
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 8 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Aged 18 to 65 years
- ASA physical status I-III
- Who received craniotomy and intracranial mass excision
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship on The Surgical Pleth Index Values Observed at The End of The Surgical Procedure With Postoperative Pain Score and Analgesia Consumption
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.
Read the detailed description
After arrival in the operating room, patients were monitored with electrocardiogram (ECG), non-invasive arterial pressure measurement, pulse oximetry, neuromuscular monitoring (GE Datex, Ohmeda TOF module), entropy (GE Datex, Ohmeda Entropy Module) and SPI. Intravenous midazolam (0.03-0.05 mg/kg), fentanyl (1mcg/kg) were used before induction of anaesthesia. For anesthetic induction, propofol was administered until the entropy value fell below 60, followed by rocuronium was performed intravenous 0.6mg/kg. Patients were intubated with endotracheal tube than the mechanical ventilation was initiated with a mixture of O2 and air with FiO2 0.5 and adjusted to maintain end-tidal CO2 pressure of 35 and 40 mmHg. Intravenous propofol and remifentanil infusion were used for anesthesia maintenance and entropy was maintained below 60. Furthermore, SPI was maintained below 50.
Tenoxicam 20 mg, paracetamol 1 g and 0.5 mg/kg tramadol intravenously were administered 30 minutes before the end of the surgery to each patient who had no contraindications. After the last suture, the anesthetic agents were stopped and was considered the end of the surgery. Then SPI data were recorded at one-minute intervals during the last five minutes (6 times in total) until the entropy value reached 60. Patients who has cooperation were extubated and taken to the recovery room. The first time that the patients cooperated in the recovery room was considered as the zeroth minute. During the postoperative observation, the patient's pain score was questioned using the Numeric Rating Scale (NRS) every five minutes. If NRS≥4, intravenous tramadol 10 mg (100 mg as the maximum dose) was administered to the patient. The patient was followed in the recovery room for 30 minutes and until NRS <4. However, if NRS≥4 was still present at the end of the observation period, an additional 2 mg dose of morphine was administered. The maximum dose of morphine was determined as 0.1mg/kg.
- Conditions
- Acute Pain, Analgesia
- Being tested
- Surgical Pleth Index (SPI)
- Keywords
- Surgical pleth index, Craniotomy
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Jan 2019
- Primary completion1 Jun 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Hundur, Istanbul University
- Investigators
- Mukadder Orhan Sungur, Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147714
- Sponsor's protocol ID
- 2018/936
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship on The Surgical Pleth Index Values Observed at The End of The Surgical Procedure With Postoperative Pain Score and Analgesia Consumption
- ClinicalTrials.gov ID
- NCT05147714
- Acronym / sponsor ID
- 2018/936
- Conditions
- Acute Pain, Analgesia
- Keywords
- Surgical pleth index, Craniotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After arrival in the operating room, patients were monitored with electrocardiogram (ECG), non-invasive arterial pressure measurement, pulse oximetry, neuromuscular monitoring (GE Datex, Ohmeda TOF module), entropy (GE Datex, Ohmeda Entropy Module) and SPI. Intravenous midazolam (0.03-0.05 mg/kg), fentanyl (1mcg/kg) were used before induction of anaesthesia. For anesthetic induction, propofol was administered until the entropy value fell below 60, followed by rocuronium was performed intravenous 0.6mg/kg. Patients were intubated with endotracheal tube than the mechanical ventilation was initiated with a mixture of O2 and air with FiO2 0.5 and adjusted to maintain end-tidal CO2 pressure of 35 and 40 mmHg. Intravenous propofol and remifentanil infusion were used for anesthesia maintenance and entropy was maintained below 60. Furthermore, SPI was maintained below 50.
Tenoxicam 20 mg, paracetamol 1 g and 0.5 mg/kg tramadol intravenously were administered 30 minutes before the end of the surgery to each patient who had no contraindications. After the last suture, the anesthetic agents were stopped and was considered the end of the surgery. Then SPI data were recorded at one-minute intervals during the last five minutes (6 times in total) until the entropy value reached 60. Patients who has cooperation were extubated and taken to the recovery room. The first time that the patients cooperated in the recovery room was considered as the zeroth minute. During the postoperative observation, the patient's pain score was questioned using the Numeric Rating Scale (NRS) every five minutes. If NRS≥4, intravenous tramadol 10 mg (100 mg as the maximum dose) was administered to the patient. The patient was followed in the recovery room for 30 minutes and until NRS <4. However, if NRS≥4 was still present at the end of the observation period, an additional 2 mg dose of morphine was administered. The maximum dose of morphine was determined as 0.1mg/kg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Aged 18 to 65 years
- ASA physical status I-III
- Who received craniotomy and intracranial mass excision
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Pleth Index (SPI)SPI data were recorded at one-minute intervals during the last five minutes (6 times in total) until the entropy value reached 60 | Device | – |
Primary outcome
Acute Postoperative Pain
Time frame: Postoperative 30 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mukadder Orhan Sungur, Prof. study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Analgesia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Postoperative Pain (time frame: Postoperative 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.