Trial Outcomes & Findings for Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer (NCT NCT02550795)
NCT ID: NCT02550795
Last Updated: 2020-08-24
Results Overview
Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea \>5 points on the numeric rating scale
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Changes from baseline in postoperative nausea at 30 min
Results posted on
2020-08-24
Participant Flow
There was no one who excluded before assignment to groups
Participant milestones
| Measure |
Control
administration of 0.9% normal saline 10ml
Control: administration of normal saline
|
Dexmedetomidine
administration of 0.5ug/kg of dexmedetomidine (5ml)
Dexmedetomidine: administration of dexmedetomidine only
|
Dexmedetomidine and Dexamethasone
administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control
administration of 0.9% normal saline 10ml
Control: administration of normal saline
|
Dexmedetomidine
administration of 0.5ug/kg of dexmedetomidine (5ml)
Dexmedetomidine: administration of dexmedetomidine only
|
Dexmedetomidine and Dexamethasone
administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
one patient excluded from the analysis according to changes of surgery method
Baseline characteristics by cohort
| Measure |
Control
n=50 Participants
administration of 0.9% normal saline 10ml
Control: administration of normal saline
|
Dexmedetomidine
n=50 Participants
administration of 0.5ug/kg of dexmedetomidine (5ml)
Dexmedetomidine: administration of dexmedetomidine only
|
Dexmedetomidine and Dexamethasone
n=50 Participants
administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 6.4 • n=50 Participants • one patient excluded from the analysis according to changes of surgery method
|
48.2 years
STANDARD_DEVIATION 7.1 • n=49 Participants • one patient excluded from the analysis according to changes of surgery method
|
48.4 years
STANDARD_DEVIATION 7.5 • n=50 Participants • one patient excluded from the analysis according to changes of surgery method
|
48.5 years
STANDARD_DEVIATION 7.0 • n=149 Participants • one patient excluded from the analysis according to changes of surgery method
|
|
Sex: Female, Male
Female
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
150 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Region of Enrollment
South Korea
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
150 participants
n=150 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline in postoperative nausea at 30 minPopulation: Patients who underwent breast cancer surgery
Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea \>5 points on the numeric rating scale
Outcome measures
| Measure |
Control
n=50 Participants
administration of 0.9% normal saline 10ml
Control: administration of normal saline
|
Dexmedetomidine
n=49 Participants
administration of 0.5ug/kg of dexmedetomidine (5ml)
Dexmedetomidine: administration of dexmedetomidine only
|
Dexmedetomidine and Dexamethasone
n=50 Participants
administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone
|
|---|---|---|---|
|
Postoperative Nausea (Numeric Rating Scale for Nausea)
|
0 scores on a scale
Interval 0.0 to 0.25
|
0 scores on a scale
Interval 0.0 to 0.0
|
0 scores on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Changes from baseline in postoperative nausea at 30 minPopulation: Patients who underwent breast cancer surgery
frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively
Outcome measures
| Measure |
Control
n=50 Participants
administration of 0.9% normal saline 10ml
Control: administration of normal saline
|
Dexmedetomidine
n=49 Participants
administration of 0.5ug/kg of dexmedetomidine (5ml)
Dexmedetomidine: administration of dexmedetomidine only
|
Dexmedetomidine and Dexamethasone
n=50 Participants
administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone
|
|---|---|---|---|
|
Postoperative Vomiting (Number of Participants With Vomiting)
0-1 hour
|
4 participants
|
0 participants
|
0 participants
|
|
Postoperative Vomiting (Number of Participants With Vomiting)
1-6 hour
|
15 participants
|
6 participants
|
1 participants
|
|
Postoperative Vomiting (Number of Participants With Vomiting)
6-24hour
|
9 participants
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: assessed at 6 and 24 hour after operative endRhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0\~4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome
Outcome measures
| Measure |
Control
n=50 Participants
administration of 0.9% normal saline 10ml
Control: administration of normal saline
|
Dexmedetomidine
n=49 Participants
administration of 0.5ug/kg of dexmedetomidine (5ml)
Dexmedetomidine: administration of dexmedetomidine only
|
Dexmedetomidine and Dexamethasone
n=50 Participants
administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone
|
|---|---|---|---|
|
Rhodes Index Score
1-6 hour after surgery
|
5 score on a scale
Interval 0.0 to 12.0
|
0 score on a scale
Interval 0.0 to 5.5
|
0 score on a scale
Interval 0.0 to 0.5
|
|
Rhodes Index Score
6-24 hour after surgery
|
3.5 score on a scale
Interval 0.0 to 13.0
|
0 score on a scale
Interval 0.0 to 3.5
|
0 score on a scale
Interval 0.0 to 0.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine and Dexamethasone
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