Clinical trial NCT02973581: SPI-directed Analgesia for Vitreoretinal Surgeries
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreoretinal Surgeries
Postoperative Nausea and Vomiting
Postoperative Pain
Keywords: Surgical Pleth Index (SPI)
General Anaesthesia (GA),
Numerical Rating Scale (NRS)
Adequacy of Anaesthesia (AoA)
Peribulbar Block (PBB)
Topical Analgesia (TA)
Oculocardiac reflex (OCR)
Postoperative nausea nad vomiting (PONV)
paracetamol
metamizol
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Silesian University of Medicine
First posted: 2016-11-25
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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 parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.

Eligibility criteria: 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 anaesthetics or metamizole
* necessity of administration of vasoactive drugs influencing SPI monitoring
* pregnancy

Primary outcomes:
measure: pain perception intraoperatively
timeFrame: intraoperatively
measure: oculocardiac reflex rate
timeFrame: intraoperatively
Secondary outcomes:
measure: pain perception postoperatively
timeFrame: up to one hour after discharge to postoperative unit.
measure: PONV
timeFrame: up to one hour
Other outcomes:
Locations:
city: Sosnowiec
country: Poland
facility: Medical University of Silesia
state: Silesia
Study officials:
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