Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535581
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Perfusion Index in the Follow-up of Postoperative Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Perfusion Index in the Follow-up of Postoperative Pain Hypertension Patient Sample
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 23AllocationRandomization 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 Ringers 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 Ringers 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 mgkg fentanyl 2 µgkg and rocuronium 06 mgkg 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 VAS6 morphine 005 mgkg 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 ΔVASVAS 0-VAS 1VAS 0 Similarly relative changes in PI were calculated using the formula ΔPIPI 0-PI 1PI 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
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 23AllocationRandomization 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 Ringers 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 Ringers 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 mgkg fentanyl 2 µgkg and rocuronium 06 mgkg 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 VAS6 morphine 005 mgkg 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 ΔVASVAS 0-VAS 1VAS 0 Similarly relative changes in PI were calculated using the formula ΔPIPI 0-PI 1PI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None