Anxiolytic effects of melatonin. A study on surgical patients.

The anxiolytic effects of melatonin: A randomized, placebo-controlled, double-blinded clinical study. - The anxiolytic effects of melatonin.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003789-25-DK

Enrollment

Registered

2014-12-12

Start date

2015-02-26

Completion date

Unknown

Last updated

2020-10-06

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

Conditions

We intend to investigate the anxiolytic effects of melatonin in relation to surgery. MedDRA version: 20.0 Level: PT Classification code 10002855 Term: Anxiety System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: Melatonin Pharmaceutical Form: Capsule, hard INN or Proposed INN: Melatonin CAS Number: 73-31-4 Other descriptive name: MELATONIN Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients who are candidates for inguinal or umbilical hernia repair Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients, who use daily opioids, benzodiazepines or melatonin Patients diagnosed with a psychiatric disorder (defined as in medical treatment) Patients with severe physical disease (ASA 3-4)? Patients with previous or ongoing alcohol or drug abuse? Patients with liver disease (defined as in medical treatment) Patients diagnosed sleep disturbances Patients who are unable to cooperate according to the protocol Patients with allergy to melatonin

Design outcomes

Primary

Measure	Time frame
Main Objective: This study's main objective is to investigate melatonins anxiolytic effects in surgical patients (inguinal or umbilical hernia). ;Secondary Objective: Quality of sleep and general well-being. ;Primary end point(s): Pre-operative anxiety (60 minutes before surgery) measured using the State-Trait Anxiety Index (STAI) ;Timepoint(s) of evaluation of this end point: STAI is measured at the preoperative interview, 60 minutes before surgery and 4 hours postoperatively.	—

Measure

Time frame

Main Objective: This study's main objective is to investigate melatonins anxiolytic effects in surgical patients (inguinal or umbilical hernia). ;Secondary Objective: Quality of sleep and general well-being. ;Primary end point(s): Pre-operative anxiety (60 minutes before surgery) measured using the State-Trait Anxiety Index (STAI) ;Timepoint(s) of evaluation of this end point: STAI is measured at the preoperative interview, 60 minutes before surgery and 4 hours postoperatively.

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Secondary

Measure	Time frame
Secondary end point(s): Postoperative anxiety (STAI) Pre- and postoperativ anxiety (VAS) Intraoperative use of remifentanil Intraoperative use of propofol Use of rescue-opioids on the ward Use of rescue-opioids in the perioperative section Perioperative sleep quality General well-being, and the degree og fatigue Time hospitalized Plasma concentrations of melatonin;Timepoint(s) of evaluation of this end point: Pre- and postoperative anxiety (stai): at the preoperative interview, 60 minutes prior to surgery and 4 hours postoperatively. Pre- and postoperative anxiety (VAS): at the preoperative interview, 60 minutes prior to surgery and 1,2 and 4 hours postoperatively. ?Perioperative sleep quality: the morning before surgery and the morning after surgery. General well-being and the degree of fatigue: the morning before surgery and the morning after surgery.	—

Measure

Time frame

Secondary end point(s): Postoperative anxiety (STAI) Pre- and postoperativ anxiety (VAS) Intraoperative use of remifentanil Intraoperative use of propofol Use of rescue-opioids on the ward Use of rescue-opioids in the perioperative section Perioperative sleep quality General well-being, and the degree og fatigue Time hospitalized Plasma concentrations of melatonin;Timepoint(s) of evaluation of this end point: Pre- and postoperative anxiety (stai): at the preoperative interview, 60 minutes prior to surgery and 4 hours postoperatively. Pre- and postoperative anxiety (VAS): at the preoperative interview, 60 minutes prior to surgery and 1,2 and 4 hours postoperatively. ?Perioperative sleep quality: the morning before surgery and the morning after surgery. General well-being and the degree of fatigue: the morning before surgery and the morning after surgery.

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Countries

Denmark

Contacts

Public ContactDennis Bregner Zetner

Department of surgery, Herlev Hospital

dennis.bregner.zetner@regionh.dk004527291376

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026