Trial Outcomes & Findings for Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery (NCT NCT01189292)
NCT ID: NCT01189292
Last Updated: 2015-07-07
Results Overview
Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point) * any PONV event within 48 hours after surgery * PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
152 participants
Primary outcome timeframe
within 48 hours after surgery
Results posted on
2015-07-07
Participant Flow
Patients older than 18 years scheduled for a primary partial or total thyroidectomy due to benign disease at the Kantonsspital St. Gallen, Department of Surgery were recruited.
Participant milestones
| Measure |
Dexamethasone Injection
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Intention to Treat Analysis
STARTED
|
76
|
76
|
|
Intention to Treat Analysis
COMPLETED
|
76
|
76
|
|
Intention to Treat Analysis
NOT COMPLETED
|
0
|
0
|
|
Per Protocol Analysis
STARTED
|
76
|
76
|
|
Per Protocol Analysis
COMPLETED
|
65
|
60
|
|
Per Protocol Analysis
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Baseline characteristics by cohort
| Measure |
Dexamethasone Injection
n=76 Participants
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=76 Participants
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
Total
n=152 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
|
70 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
76 participants
n=5 Participants
|
76 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Body mass index
|
24.8 kg/m²
STANDARD_DEVIATION 4.1 • n=5 Participants
|
25.4 kg/m²
STANDARD_DEVIATION 4.6 • n=7 Participants
|
25.1 kg/m²
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Diagnosis
Graves disease
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Diagnosis
Goiter, multinodular
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Diagnosis
Goiter, uninodular
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Type of surgery
Hemithyroidectomy
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Type of surgery
Near total thyroidectomy
|
19 participants
n=5 Participants
|
13 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Type of surgery
Total thyroidectomy
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Lymph node dissection (C1/level VI)
no
|
63 participants
n=5 Participants
|
65 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Lymph node dissection (C1/level VI)
yes
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Operating time
|
126.2 minutes
STANDARD_DEVIATION 40.9 • n=5 Participants
|
127.5 minutes
STANDARD_DEVIATION 45.7 • n=7 Participants
|
126.8 minutes
STANDARD_DEVIATION 43.2 • n=5 Participants
|
|
Specimen weight
|
45.3 gram
STANDARD_DEVIATION 40.1 • n=5 Participants
|
51.2 gram
STANDARD_DEVIATION 58.2 • n=7 Participants
|
48.3 gram
STANDARD_DEVIATION 49.9 • n=5 Participants
|
|
Histology of specimen
Papillary thyroid cancer (PTC)
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Histology of specimen
Follicular thyroid cancer (FTC)
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Histology of specimen
Benign disease
|
69 participants
n=5 Participants
|
67 participants
n=7 Participants
|
136 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 48 hours after surgeryPopulation: intention to treat analysis
Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point) * any PONV event within 48 hours after surgery * PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery
Outcome measures
| Measure |
Dexamethasone Injection
n=76 Participants
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=76 Participants
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Incidence of Postoperative Nausea and Vomiting
|
29 percentage of participants
Interval 20.0 to 40.0
|
57 percentage of participants
Interval 45.0 to 67.0
|
SECONDARY outcome
Timeframe: within 48 hours after surgery (PP)Population: per protocol analysis
Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point) * any PONV event within 48 hours after surgery * PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery
Outcome measures
| Measure |
Dexamethasone Injection
n=65 Participants
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=60 Participants
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Incidence of Postoperative Nausea and Vomiting
|
28 percentage of participants
Interval 18.0 to 40.0
|
52 percentage of participants
Interval 39.0 to 64.0
|
SECONDARY outcome
Timeframe: 4 hours after surgeryPopulation: intention to treat
mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event
Outcome measures
| Measure |
Dexamethasone Injection
n=76 Participants
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=76 Participants
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Degree of Post Operative Nausea and Vomiting
mild nausea
|
9 participants
|
15 participants
|
|
Degree of Post Operative Nausea and Vomiting
severe nausea
|
1 participants
|
3 participants
|
|
Degree of Post Operative Nausea and Vomiting
vomiting
|
3 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 8 hours after surgeryPopulation: intention to treat
mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event
Outcome measures
| Measure |
Dexamethasone Injection
n=76 Participants
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=76 Participants
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Degree of Post Operative Nausea and Vomiting
mild nausea
|
5 participants
|
7 participants
|
|
Degree of Post Operative Nausea and Vomiting
severe nausea
|
0 participants
|
3 participants
|
|
Degree of Post Operative Nausea and Vomiting
vomiting
|
8 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 4 and 8 hours after surgeryPopulation: intention to treat analysis
Compare grade of pain between the treatment (dexamethasone) and the control (saline) group * Pain was measured using a verbal rating scale ranging from 0 (no pain) to 10 in steps of 1 * before obtaining the pain rating, patients were asked to turn their heads (physical stress)
Outcome measures
| Measure |
Dexamethasone Injection
n=76 Participants
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=76 Participants
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Postoperative Pain After Physical Stress
4 hours after surgery
|
1.88 units on a scale
Standard Deviation 1.52
|
2.09 units on a scale
Standard Deviation 1.73
|
|
Postoperative Pain After Physical Stress
8 hours after surgery
|
1.88 units on a scale
Standard Deviation 1.54
|
2.01 units on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Difference between day of admission and day of dischargePopulation: intention to treat
Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group
Outcome measures
| Measure |
Dexamethasone Injection
n=76 Participants
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=76 Participants
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Length of Hospital Stay
|
48.3 hour
Standard Deviation 15.7
|
48.1 hour
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: measured from beginning of anaesthesia to end of anaesthesiaCompare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group
Outcome measures
| Measure |
Dexamethasone Injection
n=76 Participants
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=76 Participants
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Necessary Anesthesiological Medication
Propofol
|
1097 milligram
Standard Deviation 422
|
1168 milligram
Standard Deviation 422
|
|
Necessary Anesthesiological Medication
Remifentanil
|
1.944 milligram
Standard Deviation 1.197
|
1.978 milligram
Standard Deviation 1.111
|
|
Necessary Anesthesiological Medication
Fentanyl
|
0.427 milligram
Standard Deviation 0.111
|
0.444 milligram
Standard Deviation 0.108
|
|
Necessary Anesthesiological Medication
Rocuronium
|
38.7 milligram
Standard Deviation 7.3
|
39.7 milligram
Standard Deviation 8.3
|
Adverse Events
Dexamethasone Injection
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo (NaCl 0.9%)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexamethasone Injection
n=76 participants at risk
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
|
Placebo (NaCl 0.9%)
n=76 participants at risk
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
|---|---|---|
|
Surgical and medical procedures
surgical adverse event grade I
|
5.3%
4/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
2.6%
2/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
|
Endocrine disorders
temporary hypoparathyroidism
|
2.6%
2/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
2.6%
2/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
|
Surgical and medical procedures
bleeding requiring reoperation
|
1.3%
1/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
0.00%
0/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
|
General disorders
medical adverse events grade 1
|
1.3%
1/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
2.6%
2/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
|
Immune system disorders
Allergic reaction to metamizole
|
0.00%
0/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
1.3%
1/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
|
Endocrine disorders
hypocalcemia
|
0.00%
0/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
2.6%
2/76 • during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
|
Additional Information
Dr. Ignazio Tarantino
Department of General, Abdominal and Transplant Surgery, University of Heidelberg
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place