Phase 3
Completed N=36
Anxiolytic and Analgesic Effects of Melatonin
Source: ClinicalTrials.gov NCT02386319 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Preoperative Anxiety — 27; 28 score on a scale
◆ Published Evidence
Established
80citations · ~13 / year
Melatonin for preoperative and postoperative anxiety in adults.
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.
Linked Publications
-
Melatonin for preoperative and postoperative anxiety in adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preoperative Anxiety |
27; 28 | — |
| SECONDARY Postoperative Anxiety |
— | — |
| SECONDARY Pre- and Postoperative Anxiety |
— | — |
| SECONDARY Intraoperative Requirement of Remifentanil |
— | — |
| SECONDARY Intraoperative Requirement of Propofol |
— | — |
| SECONDARY Use of Rescue-opioids in the PACU |
— | — |
| SECONDARY Use of Rescue-opioids in the Ward |
— | — |
| SECONDARY Perioperative Sleep Quality |
— | — |
| SECONDARY General Well-being and Fatigue |
— | — |
| SECONDARY Plasma Concentrations of Melatonin |
— | — |
Eligibility 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:
- Immediate reoperation
- 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
Data sourced from ClinicalTrials.gov (NCT02386319) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.