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
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's enrollment of 165 is above the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Drug pages: Acetaminophen · Dipyrone
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: Informed consent form
Time frame: three years
Ran from Jan 2018 to primary completion in Sep 2021, 44 months.
Of 181 non-industry interventional studies with no phase under Postoperative Nausea and Vomiting, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 44 months is above that.
Counting every sponsor, half of 181 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Dipyrone · Acetaminophen
Postoperative Nausea and Vomiting →
Medical University of Silesia →