CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 165 enrolled
Drug / intervention
Metamizol +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03389243
NCT03389243N/ACompleted

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

Medical University of Silesia·interventional·Posted Jan 3, 2018·Updated Dec 15, 2023

In Brief

A clinical study evaluating Metamizol, paracetamol, and 1 other intervention for Vitreoretinal Surgeries and 2 related conditions. Completed, enrolled 165 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 3, 2018
Enrollment StartJan 15, 2018
Primary CompletionSep 16, 2021
Study CompletionDec 16, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.5 years ago

Interventions

Metamizoldrug

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

paracetamoldrug

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

paracetamol and metamizoledrug

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