Clinical Trial: SPI-directed Analgesia for Vitreoretinal Surgeries

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Influence of Surgical Pleth Index-guided Analgesia With Different Techniques on the Presence of Postoperative Pain, Nausea and Vomiting and of Oculocardiac Reflex in Patients Undergoing Vitreoretinal

Brief Summary:

The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for vitreoretineal surgery, presence of PONV and oculocardiac reflex and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.

Patients received general anaestesia 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 Summary: 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.
Sponsor: Medical University of Silesia

Current Primary Outcome:

• pain perception intraoperatively [ Time Frame: intraoperatively ]
  The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators will administer a resuce dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI value increases over 15 points in SPI scale every 5 minutes untill SPI value decreases back to baseline value. Additionally, the investigators will analyse rescue fentanyl consumption in abovementioned groups
• oculocardiac reflex rate [ Time Frame: intraoperatively ]
  The investigators will compare the rate of presence of OCR intraoperatively in studied groups

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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: either local peribulbar block or topical analgesia or intravenous infusion of either meatmizol or acetaminophen. The investigators use NRS and compare it with SPI values.
• PONV [ Time Frame: up to one hour ]
  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 vomitting and in the abovementioned case the investigators will administer a standard dose of antiemetic drug.

Original Secondary Outcome:

• 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: either local peribulbar block or topical analgesia or intravenous infusion of either meatmizol or acetaminophen. The investigators use NRS and compare it with SPI values.
• PONV [ Time Frame: up to one hour ]
  The investigators will compare the presence of PONV after emergence from GA in studied groups

Dates:
Date Received: November 22, 2016
Date Started: February 2016
Date Completion: May 2017
Last Updated: April 24, 2017
Last Verified: November 2016