Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS

Not Applicable

Completed

• Conditions: Vitreoretinal Surgeries; Postoperative Nausea and Vomiting; Postoperative Pain
• Interventions: Drug: Metamizol; Drug: paracetamol; Drug: paracetamol and metamizole

• Registration Number: NCT03389243
• Lead Sponsor: Medical University of Silesia

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

Study Timeline

• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2018-01-03
• Study Start: 2018-01-15
• Primary Completion: 2021-09-16
• Status Verified: 2022-01
• Study Completion: 2022-12-16
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
metamizol	paracetamol and metamizole	analgesic drug
paracetamol	paracetamol and metamizole	analgesic drug
metamizole & paracetamol	Metamizol	analgesic drugs
metamizol	paracetamol	analgesic drug
paracetamol	Metamizol	analgesic drug
metamizole & paracetamol	paracetamol	analgesic drugs

Primary Outcome Measures

Name	Time	Method
pain perception intraoperatively	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 Outcome Measures

Name	Time	Method
pain perception postoperatively	up to one hour after discharge to postoperative unit.	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.
oculocardiac reflex rate	intraoperatively	The investigators will compare the rate of presence of OCR intraoperatively in studied groups
PONV	up to 24 hours	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.

Trial Locations

Locations (1)

Medical University of Silesia; 🇵🇱 Sosnowiec, Silesia, Poland