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Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS

NCT03389243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2023-12-15

No results posted yet for this study

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.

Conditions

  • Vitreoretinal Surgeries
  • Postoperative Nausea and Vomiting
  • Postoperative Pain

Interventions

DRUG

Metamizol

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

DRUG

paracetamol

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

DRUG

paracetamol and metamizole

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

Sponsors & Collaborators

  • Silesian University of Medicine

    collaborator OTHER

  • Medical University of Silesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2021-09-16
Completion
2022-12-16

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389243 on ClinicalTrials.gov