Trial Outcomes & Findings for Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery (NCT NCT01505465)

Results Overview

Sleep time change from 96 hours before surgery to 72 hours after surgery

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

96 hours before surgery to 72 hours after surgery

Results posted on

2022-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Study: Melatonin Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.	Control: Placebo Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
Overall Study STARTED	25	25
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study: Melatonin n=19 Participants Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.	Control: Placebo n=18 Participants Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery	Total n=37 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 65.8 • n=19 Participants	61.4 years STANDARD_DEVIATION 14.3 • n=18 Participants	65.82 years STANDARD_DEVIATION 40.05 • n=37 Participants
Sex: Female, Male Female	14 Participants n=19 Participants	6 Participants n=18 Participants	20 Participants n=37 Participants
Sex: Female, Male Male	5 Participants n=19 Participants	12 Participants n=18 Participants	17 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	19 Participants n=19 Participants	18 Participants n=18 Participants	37 Participants n=37 Participants

PRIMARY outcome

Timeframe: 96 hours before surgery to 72 hours after surgery

Sleep time change from 96 hours before surgery to 72 hours after surgery

Outcome measures

Outcome measures
Measure	Study: Melatonin n=19 Participants Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.	Control: Placebo n=18 Participants Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
Perioperative Sleep Efficiency	20 minutes Interval -25.0 to 50.0	-55 minutes Interval -100.0 to -25.0

SECONDARY outcome

Timeframe: Up to postoperative day 3

Population: DATA NOT COLLECTED

A difference in 25% in average pain score at each time point be considered clinically significant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to postoperative day 3

Population: DATA NOT COLLECTED

A difference of 25% will be considered clinically important.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to postoperative day 3

Population: DATA NOT COLLECTED

A 20% difference will be considered clinically important.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 days

Population: DATA NOT COLLECTED

A 25% in narcotic usage will be considered clinically important

Outcome measures

Outcome data not reported

Adverse Events

Study: Melatonin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control: 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

Dr. Memtsoudis

HSS

Phone: (212) 606-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place