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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 : March 22, 2019
Sponsor:
Collaborator:
Silesian University of Medicine
Information provided by (Responsible Party):
Medical University of Silesia

Tracking Information
First Submitted Date  ICMJE December 27, 2017
First Posted Date  ICMJE January 3, 2018
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE January 15, 2018
Estimated Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03389243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
  • 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.
  • 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.
  • oculocardiac reflex rate [ Time Frame: intraoperatively ]
    The investigators will compare the rate of presence of OCR intraoperatively in studied groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS
Official Title  ICMJE 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
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Vitreoretinal Surgeries
  • Postoperative Nausea and Vomiting
  • Postoperative Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: metamizol
    analgesic drug
    Interventions:
    • Drug: paracetamol
    • Drug: paracetamol and metamizole
  • Experimental: paracetamol
    analgesic drug
    Interventions:
    • Drug: Metamizol
    • Drug: paracetamol and metamizole
  • Experimental: metamizole & paracetamol
    analgesic drugs
    Interventions:
    • Drug: Metamizol
    • Drug: paracetamol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 10, 2020
Estimated Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michał Stasiowski, MD 696797922 ext 0048 mstasiowski.anest@gmail.com
Contact: Lech Krawczyk, PhDr 323682341 ext 0048 lech.kraw@gmail.com
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03389243
Other Study ID Numbers  ICMJE SilesianMUKOAiIT7
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: article in Anesthesiology and Intensive Therapy in 2020, case reports
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Medical University of Silesia
Study Sponsor  ICMJE Medical University of Silesia
Collaborators  ICMJE Silesian University of Medicine
Investigators  ICMJE Not Provided
PRS Account Medical University of Silesia
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP