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
Overview
- Phase
- Not Applicable
- Intervention
- Metamizol
- Conditions
- Vitreoretinal Surgeries
- Sponsor
- Medical University of Silesia
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- pain perception intraoperatively
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Michał Stasiowski
Principal Investigator, Department of Anaesthesiology and Intensive Therapy
Medical University of Silesia
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
Exclusion Criteria
- Not provided
Arms & Interventions
metamizol
analgesic drug
Intervention: Metamizol
metamizol
analgesic drug
Intervention: 0,5 % bupivacaine with of 2% lidocaine
acetaminophen
analgesic drug
Intervention: Metamizol
acetaminophen
analgesic drug
Intervention: 0,5 % bupivacaine with of 2% lidocaine
acetaminophen
analgesic drug
Intervention: Proxymetacaine
0,5 % bupivacaine with of 2% lidocaine
a volume of 5 ml of analgesic solution for regional peribulbar block
Intervention: Acetaminophen
0,5 % bupivacaine with of 2% lidocaine
a volume of 5 ml of analgesic solution for regional peribulbar block
Intervention: 0,5 % bupivacaine with of 2% lidocaine
0,5 % bupivacaine with of 2% lidocaine
a volume of 5 ml of analgesic solution for regional peribulbar block
Intervention: Proxymetacaine
Proxymetacaine
topical analgesia
Intervention: Acetaminophen
Proxymetacaine
topical analgesia
Intervention: Proxymetacaine
control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
Intervention: Metamizol
control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
Intervention: Acetaminophen
control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
Intervention: 0,5 % bupivacaine with of 2% lidocaine
control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
Intervention: Proxymetacaine
Outcomes
Primary Outcomes
pain perception intraoperatively
Time Frame: intraoperatively
The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively. The investigators will administer a rescue 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 until 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
Secondary Outcomes
- pain perception postoperatively(up to one hour after discharge to postoperative unit.)
- PONV(up to one hour)