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

Sponsor

Medical University of Silesia (Other)

Overall Status

Recruiting

CT.gov ID

NCT03389243

Collaborator

Silesian University of Medicine (Other)

165

Enrollment

Location

Arms

52.8

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitreoretinal Surgeries Postoperative Nausea and Vomiting Postoperative Pain	Drug: Metamizol Drug: paracetamol Drug: paracetamol and metamizole	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

165 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 :

Jan 15, 2018

Anticipated Primary Completion Date :

Jun 10, 2022

Anticipated Study Completion Date :

Jun 10, 2022

Arms and Interventions

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 Names: 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 Names: 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

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 Names:

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 Names:

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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