CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 176 enrolled
Drug / intervention
Metamizol +3 moredrug
Likely dose
Acetaminophen 15 mgfrom 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/NCT02973581
NCT02973581N/ACompleted

Influence of Surgical Pleth Index-guided Analgesia Using Different Techniques on the Perioperative Outcomes in Patients Undergoing Vitreoretinal Surgery Under General Anaesthesia: Randomised, Controlled Trial

Medical University of Silesia·interventional·Posted Nov 25, 2016·Updated Jan 23, 2018

In Brief

A clinical study evaluating Metamizol, Acetaminophen, and 2 other interventions for Vitreoretinal Surgeries and 2 related conditions. Completed, enrolled 176 participants across 1 site.

Detailed Summary

The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for vitreoretinal surgeries (VRS), presence of PONV and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively. Patients received general anaesthesia alone or combined with either preemptive analgesia using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2% lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of acetaminophen in a doseof 10-15mg/kg of body weight.

Study Details

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

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 25, 2016
Enrollment StartFeb 1, 2016
Primary CompletionFeb 1, 2017
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.6 years ago

Interventions

Metamizoldrug

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

Acetaminophendrug

in group P patients will receive pre-emptive analgesia using intravenous infusion of acetaminophen in a single dose of 10-15 mg per kg of body weight

0,5 % bupivacaine with of 2% lidocainedrug

in group PBB patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)

Proxymetacainedrug

in group T patients will receive topical analgesia using a solution of 0,5% Alcaine