Anxiolytic and Analgesic Effects of Melatonin

• Status: Completed
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study's main objective is to investigate melatonin's anxiolytic and sleep-regulating effects in patients undergoing surgery. Moreover, the investigators intend to investigate the pharmacokinetic parameters of melatonin in this patient population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herlev Hospital
• Treatments: Analgesics; Anti-Anxiety Agents; Melatonin

Criteria

Inclusion Criteria part one:

• Patients who are candidates for breast surgery.

• BMI between 18 and 30

• Visible veins in the elbow region

• Fertile women use anti-contraception and have performed a negative pregnancy test

Exclusion Criteria part one:

• 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

Inclusion Criteria part two:

• Male patients who are candidates for inguinal or umbilical hernia reapir

Exclusion Criteria part two:

• 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

Withdrawal- and drop-out criteria part 2:

• Patients can withdraw at any time during trial

• Complications during surgery occur that lead to:

1. Immediate reoperation

2. Hospitalization to intensive care unit

• If it is considered in the best interest of the patients physical- and psychological health to withdraw from the trial