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A Randomized Study with the use of Melatonin as Complementary Therapy to the Regimen of Analgesia and Sedation in Intensive Care: Analysis of Serum Levels

A Randomized Study with the use of Melatonin as Adjuvant to the Analgesic Regimen in Intensive Care: Analysis of Serum Levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4d9cv7
Enrollment
Unknown
Registered
2018-12-12
Start date
2018-09-25
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

Sleep

Interventions

Patients were randomized to receive melatonin - 10 mg orally or nasoenteric tube (in patients unable to swallow) or placebo administered at 8 pm for a maximum of 7 days. An unblinded pharmacist random
Drug
Procedure/surgery
E01.370.225.998.110
D03.633.100.473.914.481

Sponsors

Faculdade de Medicina de São José do Rio Preto - FAMERP
Lead Sponsor
Faculdade de Medicina de São José do Rio Preto - FAMERP
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted to the ICU in the surgery postoperative, polytraumatized, with severe infection or sepsis, using analgesics and or sedatives, with the possibility of using the GIT within 48 h after admission to the ICU, both genders and above age of 18 years.

Exclusion criteria

Exclusion criteria: Patients considered unable to answer questionnaires, patients with a history of seizures, neurological or psychiatric diseases, sleep apnea, deaf or mute, with renal or hepatic failure, intestinal obstruction or other condition that would affect intestinal absorption, pregnancy, lactation and diseases autoimmune

Design outcomes

Primary

MeasureTime frame
Evaluate if the use of melatonin as an adjunct to the analgesic regimen in ICU patients improves sleep quality—

Secondary

MeasureTime frame
Evaluate if the use of melatonin as an adjunct to the analgesic regimen in ICU patients reduces the incidence of delirium and decreases the need for analgesics and sedatives;Evaluate if higher serum levels of melatonin imply improvement in the quality of sleep, measured by the enzyme-linked immunosorbent assay (ELISA)—

Countries

Brazil

Contacts

Public ContactSuzana Lobo

Faculdade de Medicina de São José do Rio Preto - FAMERP

joelmavg@gmail.com+5501732015905

Outcome results

None listed

Source: REBEC (via WHO ICTRP)