Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS (P&MSPIVRS)

Medical University of Silesia

Status: Completed

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Vitreoretinal Surgeries

Treatments: Drug: Metamizol; Drug: paracetamol; Drug: paracetamol and metamizole

Study type: Interventional

Funder types: Other

Identifiers

NCT03389243

SilesianMUKOAiIT7

Details and patient eligibility

About

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.

Full 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

Enrollment: 165 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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165 participants in 3 patient groups

metamizol

Experimental group

Description:

analgesic drug

Treatment:

Drug: paracetamol and metamizole

Drug: paracetamol

paracetamol

Experimental group

Description:

analgesic drug

Treatment:

Drug: paracetamol and metamizole

Drug: Metamizol

metamizole & paracetamol

Experimental group

Description:

analgesic drugs

Treatment:

Drug: paracetamol

Drug: Metamizol