Influence of SPI-guided Analgesia With Preemptive Analgesia Using Either Paracetamol or Metamizole on the Presence of Oculocardiac Reflex, Postoperative Pain, Postoperative Nausea and Vomiting in Patients Undergoing VRS Under General Anaesthesia: a Randomised, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- paracetamol
- Conditions
- Vitreoretinal Surgeries
- Sponsor
- Medical University of Silesia
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- pain perception intraoperatively
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •written consent to participate in the study
- •written consent to undergo general anaesthesia alone or combined with different techniques of pre-emptive analgesia and vitreoretinal surgery
Exclusion Criteria
- •history of allergy to local paracetamol or metamizole
- •necessity of administration of vasoactive drugs influencing SPI monitoring
- •pregnancy
Arms & Interventions
metamizol
analgesic drug
Intervention: paracetamol
metamizol
analgesic drug
Intervention: paracetamol and metamizole
paracetamol
analgesic drug
Intervention: Metamizol
paracetamol
analgesic drug
Intervention: paracetamol and metamizole
metamizole & paracetamol
analgesic drugs
Intervention: Metamizol
metamizole & paracetamol
analgesic drugs
Intervention: paracetamol
Outcomes
Primary Outcomes
pain perception intraoperatively
Time Frame: 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
Secondary Outcomes
- pain perception postoperatively(up to one hour after discharge to postoperative unit.)
- oculocardiac reflex rate(intraoperatively)
- PONV(up to 24 hours)