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

Primary Purpose

Vitreoretinal Surgeries, Postoperative Nausea and Vomiting, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Metamizol
paracetamol
paracetamol and metamizole
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitreoretinal Surgeries focused on measuring Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Rating Scale (NRS), Adequacy of Anaesthesia (AoA), Oculocardiac reflex (OCR), paracetamol, metamizole

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of SilesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

metamizol

paracetamol

metamizole & paracetamol

Arm Description

analgesic drug

analgesic drug

analgesic drugs

Outcomes

Primary Outcome Measures

pain perception 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

pain perception postoperatively
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
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
The investigators will compare the rate of presence of OCR intraoperatively in studied groups

Full Information

First Posted
December 27, 2017
Last Updated
February 2, 2022
Sponsor
Medical University of Silesia
Collaborators
Silesian University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03389243
Brief Title
Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS
Acronym
P&MSPIVRS
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
June 10, 2022 (Anticipated)
Study Completion Date
June 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Silesia
Collaborators
Silesian University of Medicine

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreoretinal Surgeries, Postoperative Nausea and Vomiting, Postoperative Pain
Keywords
Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Rating Scale (NRS), Adequacy of Anaesthesia (AoA), Oculocardiac reflex (OCR), paracetamol, metamizole

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metamizol
Arm Type
Experimental
Arm Description
analgesic drug
Arm Title
paracetamol
Arm Type
Experimental
Arm Description
analgesic drug
Arm Title
metamizole & paracetamol
Arm Type
Experimental
Arm Description
analgesic drugs
Intervention Type
Drug
Intervention Name(s)
Metamizol
Other Intervention Name(s)
Pyralgin
Intervention Description
in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Description
in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
Intervention Type
Drug
Intervention Name(s)
paracetamol and metamizole
Intervention Description
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
Primary Outcome Measure Information:
Title
pain perception intraoperatively
Description
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
Time Frame
intraoperatively
Secondary Outcome Measure Information:
Title
pain perception postoperatively
Description
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.
Time Frame
up to one hour after discharge to postoperative unit.
Title
PONV
Description
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.
Time Frame
up to 24 hours
Title
oculocardiac reflex rate
Description
The investigators will compare the rate of presence of OCR intraoperatively in studied groups
Time Frame
intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 paracetamol or metamizole necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michał Stasiowski, MD
Phone
696797922
Ext
0048
Email
mstasiowski.anest@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lech Krawczyk, PhDr
Phone
323682341
Ext
0048
Email
lech.kraw@gmail.com
Facility Information:
Facility Name
Medical University of Silesia
City
Sosnowiec
State/Province
Silesia
ZIP/Postal Code
41-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michał Stasiowski, MD
Phone
696797922
Ext
0048
Email
mstasiowski.anest@gmail.com
First Name & Middle Initial & Last Name & Degree
Lech Krawczyk, Ph Dr
Phone
323682341
Ext
0048
Email
lech.kraw@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
article in Anesthesiology and Intensive Therapy in 2020, case reports
Citations:
PubMed Identifier
25032676
Citation
Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.
Results Reference
result
PubMed Identifier
23471754
Citation
Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
Results Reference
result
PubMed Identifier
24012235
Citation
Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
Results Reference
result
PubMed Identifier
24535604
Citation
Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
Results Reference
result
PubMed Identifier
11756886
Citation
Fekrat S, Elsing SH, Raja SC, Campochiaro PA, de Juan E Jr, Haller JA. Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina. 2001;21(6):627-32. doi: 10.1097/00006982-200112000-00010.
Results Reference
result
PubMed Identifier
10486687
Citation
Mandelcorn M, Taback N, Mandelcorn E, Ananthanarayan C. Risk factors for pain and nausea following retinal and vitreous surgery under conscious sedation. Can J Ophthalmol. 1999 Aug;34(5):281-5.
Results Reference
result

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Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS

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