An interventional study of Metamizol and paracetamol in Vitreoretinal Surgeries, Postoperative Nausea and Vomiting and Postoperative Pain, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Medical University of Silesia · Not applicable, Interventional, and Prevention
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
Exclusion Criteria:
analgesic drug
Drug: paracetamol · Drug: paracetamol and metamizole
analgesic drug
Drug: Metamizol · Drug: paracetamol and metamizole
analgesic drugs
Drug: Metamizol · Drug: paracetamol
in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
Also known as: Pyralgin
in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
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
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
Time frame: intraoperatively
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.
Time frame: up to one hour after discharge to postoperative unit.
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.
Time frame: up to 24 hours
oculocardiac reflex rate
The investigators will compare the rate of presence of OCR intraoperatively in studied groups
Time frame: intraoperatively
Plan to share: Yes — article in Pharmaceuticals in 2024, case reports
Supporting information: Icf
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Medical University of Silesia