Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS

NCT03389243 | Completed

• 1 other identifier: SilesianMUKOAiIT7
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  intraoperatively

Secondary Outcomes (3)

• pain perception postoperatively

  up to one hour after discharge to postoperative unit.

• PONV

  up to 24 hours

• oculocardiac reflex rate

  intraoperatively

Study Arms (3)

metamizol

EXPERIMENTAL

analgesic drug

Drug: paracetamol; Drug: paracetamol and metamizole

paracetamol

EXPERIMENTAL

analgesic drug

Drug: Metamizol; Drug: paracetamol and metamizole

metamizole & paracetamol

EXPERIMENTAL

analgesic drugs

Drug: Metamizol; Drug: paracetamol

Interventions

Metamizol DRUG

in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram

Also known as: Pyralgin

metamizole & paracetamol; paracetamol

paracetamol DRUG

in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram

metamizol; metamizole & paracetamol

paracetamol and metamizole DRUG

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

metamizol; paracetamol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• history of allergy to local paracetamol or metamizole
• necessity of administration of vasoactive drugs influencing SPI monitoring
• pregnancy

Sponsors & Collaborators

• Medical University of Silesia: lead
• Silesian University of Medicine: collaborator

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Related Publications (6)

• 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.

  PMID: 25032676 RESULT

• 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.

  PMID: 23471754 RESULT

• 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.

  PMID: 24012235 RESULT

• 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.

  PMID: 24535604 RESULT

• 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.

  PMID: 11756886 RESULT

• 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.

  PMID: 10486687 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Dipyrone; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 3, 2018
• Study Start: January 15, 2018
• Primary Completion: September 16, 2021
• Study Completion: December 16, 2022
• Last Updated: December 15, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: three years

Locations

PL (1)