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Perfusion; ComplicationsNCT06535581

Perfusion Index in the Follow-up of Postoperative Pain

An observational study of Perfusion; Complications, run by Amasya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: The effect of the perfusion index (PI) as an indicator of postoperative pain was investigated. To this end, the presence of the perfusion index in predicting the need for analgesia and its effect in hypertensive patients were investigated. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Perfusion; Complications
What is being tested?
surgery patient
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Apr 2023to 1 Jun 2024
How long will I take part?
1 Day
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: laparotomy abdominal surgery under general anesthesia.

Who may be able to join

  • American Society of Anesthesiologists physical statuses ranging from 1 to 3, who were scheduled to undergo laparotomy abdominal surgery under general anesthesia.

Who cannot join

  • Patients with difficult cooperation and heart failure

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Amasya University Training and Research Hospital

    Amasya, 05100

Other trials in Turkey (Türkiye)

About this study

Official title: Perfusion Index in the Follow-up of Postoperative Pain; Hypertension Patient Sample

Background: The effect of the perfusion index (PI) as an indicator of postoperative pain was investigated. To this end, the presence of the perfusion index in predicting the need for analgesia and its effect in hypertensive patients were investigated. Researher aimed to investigate the change in perfusion index in the prediction of postoperative pain after laparotomic abdominal surgery. As a secondary aim, the results of the relative change in perfusion index in the presence of hypertensive disease were analysed. Methods: A total of 100 patients with ASA 1-3 with or without hypertension who were scheduled to undergo open abdominal surgery between 1 April 2023 and 30 November 2023 were included in the study. The relative variability of visual analogue scale (VAS) and PI in patients receiving postoperative analgesia was examined. The degree of prediction of postoperative pain by these variables after rescue analgesia was investigated. Hypertensive patients were analysed along with other patient groups.

Read the detailed description

In this prospective randomized single-blind cohort study, postoperative visual analog scale and perfusion index change were examined. Relative changes in VAS and PI were analyzed.

Researher included a total of 100 adult participants with American Society of Anesthesiologists physical statuses ranging from 1 to 3, who were scheduled to undergo laparotomy abdominal surgery under general anesthesia. Exclusion criteria were as follows: Patients with difficult cooperation and heart failure were excluded from the study 2.3Allocation,Randomization On the day of surgery, patients without hypertension disease (Group 1) and those with hypertension disease (Group 2) were separated and taken into surgery. Routine electrocardiography (ECG), pulse oximetry and blood pressure monitoring and pulse oximetry devices (Masimo Corp, Irvine CA, USA) were used to record mean arterial pressure (MAP), PI and pleth variability index (PVI) values at the start of anaesthesia.

The study was conducted at Amasya Sabuncuoğlu Şerefettin Training and Research Hospital and approved by the ethics committee with the number 2023000037-1. All studies were informed about the study and informed consent was given. All patients were routinely given 500 cc of Ringer's lactate solution intravenously in the preoperative period before anaesthesia and taken to the operating room. Written informed consent was obtained from volunteers and included in the study. . All patients received intravenous (IV) hydration with 500 cc of Ringer's lactate after a 6-hour fast. For premedication, midazolam 1 mg IV and pantoprazole 40 mg IV were administered 10 minutes before the operating room. Routine electrocardiography (ECG), pulse oximetry and blood pressure monitoring and pulse oximetry devices (Masimo Corp, Irvine CA, USA) were used to record mean arterial pressure (MAP), PVI values at the start of anaesthesia.

Propofol 2 mg/kg, fentanyl 2 µg/kg and rocuronium 0.6 mg/kg were administered intravenously to induce anaesthesia. Endotracheal intubation was performed after muscle relaxation under deep anaesthesia. Post-induction anaesthesia was maintained with sevoflurane 2%, 50-50% oxygen-air mixture. After surgery, the effect of muscle relaxation was terminated with sugammadex 200 mg and patients were transferred to the post-anaesthesia care unit when sufficient muscle strength was observed. Paracetamol 500 mg iv and tramadol 100 mg iv were administered postoperatively. Postoperative pain was assessed using a VAS. Pain was scored on a 0-10 scale, and a VAS > 6 was considered the pain cut-off point for rescue analgesia. When the patient first arrived at the post-anaesthesia care unit, a VAS 0 value was accepted and scoring was performed every 30 minutes (VAS 30, VAS 60, VAS 90). The corresponding PI 0, PI 90, PVI 0, PVI 90 values were recorded. If VAS>6, morphine 0.05 mg/kg was repeated every 15 minutes until VAS <6 as rescue analgesia. Patients with a modified Aldrete score >8 were observed and referred to the clinical unit. Relative changes in VAS score were calculated during statistical analysis. VAS 1 was taken as the last value measured after rescue analgesia in the post-anaesthesia care unit. The relative change was calculated as ( ΔVAS)=(VAS 0-VAS 1)/(VAS 0). Similarly, relative changes in PI were calculated using the formula ( ΔPI)=(PI 0-PI 1)/(PI 0). These changes were analysed in patients with hypertension (group 2) and without (group 1) hypertension. The predictive ability of postoperative pain as a tool for measuring and assessing pain was examined by analysing the relative change in the Perfuston index.

Being tested
surgery patient
Keywords
perfusion index, postoperative pain, anaesthesia
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgery patientProcedure or surgery

    patients with hypertension (group 2) and without (group 1) hypertension. The predictive ability of postoperative pain as a tool for measuring and assessing pain was examined by analysing the relative change in the Perfuston index.

Study groups in NCT06535581
Study groupRoleWhat they receive
Group 1hypertension patients
Receives: Procedure: surgery patient
group 2non hypertension patients
Receives: Procedure: surgery patient

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PI value

    The correlation between the relative change in PI value and the relative change in VAS value after anesthesia induction and postoperative pain management was investigated.

    Measured: minutes 90

  2. hypertension patient

    The relative change in PI value and the relative change in VAS value were compared in hypertensive patients and non-hypertensive patients.

    Measured: minutes 90

Secondary outcomes (1)
  1. complication

    Complications developing in all patients

    Measured: minutes 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start5 Apr 2023
  3. Primary completion1 Nov 2023
  4. Study completion1 Jun 2024

Resources

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
Other
Time perspective
Prospective
Enrolment
100 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06535581
Sponsor's protocol ID
E-76988455-050
Status last verified
Jul 2024
First submitted
26 Jul 2024
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data sources may be shared depending on the type or plan of the study.

Publications

  • Bihani P, Pandey A, Jha M, Paliwal N, Jaju R, Solanki R. Comparing Perfusion Index and Visual Analogue Scores for Postoperative Pain Assessment Following Upper Limb Surgeries Under Supraclavicular Brachial Plexus Block: An Observational Study. Cureus. 2024 Mar 4;16(3):e55529. doi: 10.7759/cureus.55529. eCollection 2024 Mar.

    PubMed 38576659
  • Kamel AAF, Medhat MM, Salem DAE, Naby SMA. Effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in nasal surgery: a randomized controlled trial. Patient Saf Surg. 2022 Aug 19;16(1):27. doi: 10.1186/s13037-022-00336-7.

    PubMed 35986325
  • Elshal MM, Hasanin AM, Mostafa M, Gamal RM. Plethysmographic Peripheral Perfusion Index: Could It Be a New Vital Sign? Front Med (Lausanne). 2021 Oct 1;8:651909. doi: 10.3389/fmed.2021.651909. eCollection 2021.

    PubMed 34660615

Questions about this trial

What is this clinical trial studying?

An observational study of Perfusion; Complications, run by Amasya 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 1 inclusion and 1 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 2 Aug 2024. 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?

PI value (time frame: minutes 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06535581, which also lists 3 linked publications.

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 2 Aug 2024.

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