Trial · NCT02386319
Anxiolytic and Analgesic Effects of Melatonin
NCT02386319, Phase 3, Completed, Herlev Hospital; results first posted 2021-09-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anxiolytic and Analgesic Effects of Melatonin. Trials, record NCT02386319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02386319
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anxiolytic and Analgesic Effects of Melatonin
- NCT number
- NCT02386319
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 36 participants, actual
- Lead sponsor
- Herlev Hospital
- Conditions
- Anxiety
- Interventions
- Melatonin, Placebo
- First posted
- 2015-03-11
- Last updated
- 2021-09-02
- Results first posted
- 2021-09-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Preoperative Anxiety | 60 minutes preoperative | The "State" scale of the State-Trait Anxiety Inventory (STAI). Construct: Current level of anxiety. Scale range: 20-40 (higher scores indicate higher level of current anxiety) Scores are calculated according to the STAI scoring manual by adding point from each item (possible point for each item is 1-4). |
| Secondary | Postoperative Anxiety | at the preoperative interview, 60 minutes prior to surgery and 4 hours postoperatively. | State-Trait Anxiety Index |
| Secondary | Pre- and Postoperative Anxiety | at the preoperative interview, 60 minutes prior to surgery, 1 and 4 hours postoperatively. | Visual analog scale |
| Secondary | Intraoperative Requirement of Remifentanil | intraopeative | µg/kg/min |
| Secondary | Intraoperative Requirement of Propofol | intraoperative | mg/kg/min |
| Secondary | Use of Rescue-opioids in the PACU | 0-24 hours postoperative | dose |
| Secondary | Use of Rescue-opioids in the Ward | 0-24 hours postoperative | dose |
| Secondary | Perioperative Sleep Quality | 24 hours | Visual analog scale |
| Secondary | General Well-being and Fatigue | 24 hours | Visual analog scale |
| Secondary | Plasma Concentrations of Melatonin | baseline, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 180 min, 240 min, 300 min, 360 min and 420 min. after melatonin administration. | pg/ml |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Preoperative Anxiety | 60 minutes preoperative | score on a scale | MEDIAN | |
| SECONDARY | Postoperative Anxiety | at the preoperative interview, 60 minutes prior to surgery and 4 hours postoperatively. | |||
| SECONDARY | Pre- and Postoperative Anxiety | at the preoperative interview, 60 minutes prior to surgery, 1 and 4 hours postoperatively. | |||
| SECONDARY | Intraoperative Requirement of Remifentanil | intraopeative | |||
| SECONDARY | Intraoperative Requirement of Propofol | intraoperative | |||
| SECONDARY | Use of Rescue-opioids in the PACU | 0-24 hours postoperative | |||
| SECONDARY | Use of Rescue-opioids in the Ward | 0-24 hours postoperative | |||
| SECONDARY | Perioperative Sleep Quality | 24 hours | |||
| SECONDARY | General Well-being and Fatigue | 24 hours | |||
| SECONDARY | Plasma Concentrations of Melatonin | baseline, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 180 min, 240 min, 300 min, 360 min and 420 min. after melatonin administration. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Preoperative Anxiety | Melatonin | 27 | Inter-Quartile Range 24 to 34 | score on a scale | |
| Preoperative Anxiety | Placebo | 28 | Inter-Quartile Range 24 to 33 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Melatonin | 18 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Melatonin | 16 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Melatonin | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melatonin | 0 | 16 |
| Total, all-cause mortality | Placebo | 0 | 17 |
| Total, other adverse events | Melatonin | 0 | 16 |
| Total, other adverse events | Placebo | 0 | 17 |
| Total, serious adverse events | Melatonin | 0 | 16 |
| Total, serious adverse events | Placebo | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33319916 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Melatonin vs Placebo: deaths from any cause | Trial comparisons |
| Melatonin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02386319
GET https://conductscience.org/api/trials/v1/NCT02386319/registered