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Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS (P&MSPIVRS)

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ClinicalTrials.gov Identifier: NCT03389243
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Silesian University of Medicine
Information provided by (Responsible Party):
Medical University of Silesia

Brief 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.


Condition or disease Intervention/treatment Phase
Vitreoretinal Surgeries Postoperative Nausea and Vomiting Postoperative Pain Drug: Metamizol Drug: paracetamol Drug: paracetamol and metamizole Not Applicable

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

Different options of preemptive analgesia are used to decrease the postoperative pain perception as well as diminish the rate of PONV by deceasing intraoperative consumption of intravenous narcotic analgesics


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : January 10, 2020
Estimated Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: metamizol
analgesic drug
Drug: paracetamol
in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
Drug: paracetamol and metamizole
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
Experimental: paracetamol
analgesic drug
Drug: Metamizol
in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
Other Name: Pyralgin
Drug: paracetamol and metamizole
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
Experimental: metamizole & paracetamol
analgesic drugs
Drug: Metamizol
in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
Other Name: Pyralgin
Drug: paracetamol
in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram



Primary Outcome Measures :
  1. pain perception intraoperatively [ Time Frame: intraoperatively ]
    The investigators will compare the efficacy of analgesia intraoperatively according to used preoperatively intravenous infusions . 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 10 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


Secondary Outcome Measures :
  1. 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: intravenous infusion of either metamizol or paracetamol or both of them. The investigators use NRS and compare it with SPI values.

  2. PONV [ Time Frame: up to 24 hours ]
    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 vomiting and in the abovementioned case the investigators will administer a standard dose of antiemetic drug.

  3. oculocardiac reflex rate [ Time Frame: intraoperatively ]
    The investigators will compare the rate of presence of OCR intraoperatively in studied groups



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 paracetamol or metamizole
  • necessity of administration of vasoactive drugs influencing SPI monitoring
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389243


Contacts
Contact: Michał Stasiowski, MD 696797922 ext 0048 mstasiowski.anest@gmail.com
Contact: Lech Krawczyk, PhDr 323682341 ext 0048 lech.kraw@gmail.com

Locations
Poland
Medical University of Silesia Recruiting
Sosnowiec, Silesia, Poland, 41-200
Contact: Michał Stasiowski, MD    696797922 ext 0048    mstasiowski.anest@gmail.com   
Contact: Lech Krawczyk, Ph Dr    323682341 ext 0048    lech.kraw@gmail.com   
Sponsors and Collaborators
Medical University of Silesia
Silesian University of Medicine

Publications of Results:
Responsible Party: Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03389243     History of Changes
Other Study ID Numbers: SilesianMUKOAiIT7
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: article in Anesthesiology and Intensive Therapy in 2020, case reports
Supporting Materials: Informed Consent Form (ICF)
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Silesia:
Surgical Pleth Index (SPI)
General Anaesthesia (GA),
Numerical Rating Scale (NRS)
Adequacy of Anaesthesia (AoA)
Oculocardiac reflex (OCR)
paracetamol
metamizole

Additional relevant MeSH terms:
Pain, Postoperative
Nausea
Vomiting
Postoperative Nausea and Vomiting
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Anesthetics
Acetaminophen
Dipyrone
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents