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| Name | Class |
|---|---|
| Silesian University of Medicine | OTHER |
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The aim of this randomized trial is to assess the efficacy of preemptive analgesia using paracetamol or metamizole or both of them under SPI-guided anaesthesia for vitreoretinal surgery (VRS), presence of PONV (postoperative nausea and vomiting) and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.
Patients will receive general anaesthesia combined with either preemptive analgesia using preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of 1,0 g of acetaminophen or both of them together.
Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.
Different options of preemptive analgesia are used to decrease the postoperative pain perception as well as diminish the rate of PONV by deceasing intraoperative consumption of intravenous narcotic analgesics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metamizol | Experimental | analgesic drug |
|
| paracetamol | Experimental | analgesic drug |
|
| metamizole & paracetamol | Experimental | analgesic drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metamizol | Drug | in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain perception intraoperatively | The investigators will compare the efficacy of analgesia intraoperatively according to used preoperatively intravenous infusions . The investigators will administer a rescue dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI value increases over 10 points in SPI scale every 5 minutes until SPI value decreases back to baseline value. Additionally, the investigators will analyse rescue fentanyl consumption in abovementioned groups | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| pain perception postoperatively | The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: intravenous infusion of either metamizol or paracetamol or both of them. The investigators use NRS and compare it with SPI values. | up to one hour after discharge to postoperative unit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Silesia | Sosnowiec | Silesian Voivodeship | 41-200 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25032676 | Result | Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17. | |
| 23471754 | Result | Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6. |
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article in Pharmaceuticals in 2024, case reports
three years
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D004177 | Dipyrone |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000632 | Aminopyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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|
| paracetamol | Drug | in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram |
|
| paracetamol and metamizole | Drug | in group PM patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram and paracetamol in a dose of 1 gram |
|
| PONV | The investigators will compare the presence of PONV after emergence from GA in studied groups. The investigators will observe patients postoperatively and record any incidence of nausea or vomiting and in the abovementioned case the investigators will administer a standard dose of antiemetic drug. | up to 24 hours |
| oculocardiac reflex rate | The investigators will compare the rate of presence of OCR intraoperatively in studied groups | intraoperatively |
| 24012235 | Result | Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007. |
| 24535604 | Result | Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16. |
| 11756886 | Result | Fekrat S, Elsing SH, Raja SC, Campochiaro PA, de Juan E Jr, Haller JA. Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina. 2001;21(6):627-32. doi: 10.1097/00006982-200112000-00010. |
| 10486687 | Result | Mandelcorn M, Taback N, Mandelcorn E, Ananthanarayan C. Risk factors for pain and nausea following retinal and vitreous surgery under conscious sedation. Can J Ophthalmol. 1999 Aug;34(5):281-5. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |