Trial Outcomes & Findings for Anxiolytic and Analgesic Effects of Melatonin (NCT NCT02386319)
NCT ID: NCT02386319
Last Updated: 2021-09-02
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
60 minutes preoperative
Results posted on
2021-09-02
Participant Flow
Participant milestones
| Measure |
Melatonin
Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery.
Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.
Melatonin: Gelatin capsules
|
Placebo
Gelatin capsules. Anxiolytic and analgesic study. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.
Placebo: Placebo capsules
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anxiolytic and Analgesic Effects of Melatonin
Baseline characteristics by cohort
| Measure |
Melatonin
n=18 Participants
Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery.
Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.
Melatonin: Gelatin capsules
|
Placebo
n=18 Participants
Gelatin capsules. Anxiolytic and analgesic study. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.
Placebo: Placebo capsules
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
60 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Hernia (inguinal/umbilical)
Inguinal hernia
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Hernia (inguinal/umbilical)
Umbilical hernia
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Surgery (laparoscopic/open)
Laparoscopic
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Surgery (laparoscopic/open)
Open
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Baseline State anxiety (at enrolment)
|
27 units on a scale
n=5 Participants
|
27 units on a scale
n=7 Participants
|
27 units on a scale
n=5 Participants
|
|
Baseline Trait anxiety (at enrolment)
|
30 units on a scale
n=5 Participants
|
27 units on a scale
n=7 Participants
|
29 units on a scale
n=5 Participants
|
|
Baseline VAS anxiety
|
5 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
5 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 minutes preoperativeThe "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).
Outcome measures
| Measure |
Melatonin
n=16 Participants
Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery.
Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.
Melatonin: Gelatin capsules
|
Placebo
n=17 Participants
Gelatin capsules. Anxiolytic and analgesic study. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.
Placebo: Placebo capsules
|
|---|---|---|
|
Preoperative Anxiety
|
27 score on a scale
Interval 24.0 to 34.0
|
28 score on a scale
Interval 24.0 to 33.0
|
SECONDARY outcome
Timeframe: at the preoperative interview, 60 minutes prior to surgery and 4 hours postoperatively.State-Trait Anxiety Index
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at the preoperative interview, 60 minutes prior to surgery, 1 and 4 hours postoperatively.Visual analog scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: intraopeativeµg/kg/min
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: intraoperativemg/kg/min
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0-24 hours postoperativedose
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0-24 hours postoperativedose
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursVisual analog scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursVisual analog scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
Adverse Events
Melatonin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place