Anxiolytic effects of melatonin. A study on surgical patients.

Phase 1

• Conditions: We intend to investigate the anxiolytic effects of melatonin in relation to surgery.; MedDRA version: 20.0Level: PTClassification code 10002855Term: AnxietySystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-003789-25-DK
• Lead Sponsor: Department of surgery, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-12
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 32

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>;Timepoint(s) of evaluation of this end point: STAI is measured at the preoperative interview, 60 minutes before surgery and 4 hours postoperatively.

Secondary Outcome Measures

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