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Evaluation of the effectiveness of a Pain Monitor for the adequacy of Analgesia in the perioperative period of Stomach Reduction surgery

Evaluation of the effectiveness of a Nociception Monitor for the adequacy of Analgesia in the perioperative period of Gastroplasties

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10zj27p5
Enrollment
Unknown
Registered
2023-10-02
Start date
2023-08-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pain

Interventions

This is a clinical, prospective, randomized, interventionist, partially blinded study because it is an intervention guided by the nociception level monitor (NOL) in patients of both sexes, submitted t

Sponsors

Fundação do ABC
Lead Sponsor
Fundação do ABC
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult men and women will be included; aged between 18 and 65 years; diagnosed with obesity who will undergo gastroplasty by videolaparoscopy' who agree to participate in the research after signing the free and informed consent form

Exclusion criteria

Exclusion criteria: Any patient who does not agree to participate in the study; ASA 3 or 4; previous use of opioids or illicit drugs; has a diagnosis of chronic pain; oncological diseases; history of cognitive psychiatric renal or neurological disorders; contraindication or allergy to any drug to be used in the study

Design outcomes

Primary

MeasureTime frame
Evaluate whether the use of the nociception monitor (NOL) changes the amount of the opioid analgesic remifentanil administered intraoperatively.

Secondary

MeasureTime frame
Evaluate whether the use of NOL during surgery changes the consumption of morphine and non-opioid analgesics in the first 48 hours after the end of surgery.;Evaluate whether the use of NOL during surgery changes the incidence of adverse events, such as intraoperative hypotension, nausea and vomiting in the first 48 hours after the end of surgery. ;To assess whether NOL use during surgery alters the time to the first rescue analgesic request after the end of surgery.

Countries

Brazil

Contacts

Public ContactGeorgiana Freire

Fundação do ABC

freire.georgiana@gmail.com+55 (011) 2829-5000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)