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NCT Number: NCT03389243

Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS

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.

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Key information

Conditions

Vitreoretinal Surgeries Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metamizol

Drug

in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram

Other names: Pyralgin

Paracetamol

Drug

in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram

paracetamol and metamizole

Drug

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

Primary outcomes

  1. 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

  1. pain perception postoperatively

    Time frame: 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.

  2. PONV

    Time frame: 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.

  3. oculocardiac reflex rate

    Time frame: intraoperatively

    The investigators will compare the rate of presence of OCR intraoperatively in studied groups

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Silesian University of Medicine

Registry information

Official study title

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

Acronym: P&MSPIVRS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jan 3, 2018
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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