Thyroid Diseases, Thyroidectomy
Conditions
Keywords
postoperative nausea and vomitus, PONV, thyroid surgery
Brief summary
The study is to 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.
Interventions
DRUGDexamethasone
8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
OTHERNaCl 0.9%
2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * Planned partial or total thyroidectomy
Exclusion criteria
* History of adverse effects to dexamethasone or propyleneglycol or di-natrium-EDTA * Patients with chronic pain * Necessity for opioids-application in the postoperative course * Not possible administration of a cervical block (0.5% bupivacaine at a dose of 20ml) * Patients with Diabetes mellitus * Pregnancy (test in young women) * Glaucoma * Patients who received antiemetic therapy within 48h before surgery * Patients with acute pain requiring painkillers others than paracetamol or more than single dose NSAR treatment within 48h before surgery * Use of psychotropic drugs * Incompliant patients * Preoperatively high suspicion of malignancy * Re-operations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting | within 48 hours after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting | within 48 hours after surgery (PP) | 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 |
| Degree of Post Operative Nausea and Vomiting | 4 hours after surgery | mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event |
| Postoperative Pain After Physical Stress | 4 and 8 hours after surgery | 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) |
| Length of Hospital Stay | Difference between day of admission and day of discharge | Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group |
| Necessary Anesthesiological Medication | measured from beginning of anaesthesia to end of anaesthesia | Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group |
Countries
Switzerland
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Injection Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery | 76 |
| Placebo (NaCl 0.9%) NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery | 76 |
| Total | 152 |
Baseline characteristics
| Characteristic | Dexamethasone Injection | Placebo (NaCl 0.9%) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 9 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 67 Participants | 137 Participants |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 12 | 48.4 years STANDARD_DEVIATION 13.4 | 49.0 years STANDARD_DEVIATION 12.7 |
| Body mass index | 24.8 kg/m² STANDARD_DEVIATION 4.1 | 25.4 kg/m² STANDARD_DEVIATION 4.6 | 25.1 kg/m² STANDARD_DEVIATION 4.4 |
| Diagnosis Goiter, multinodular | 35 participants | 33 participants | 68 participants |
| Diagnosis Goiter, uninodular | 28 participants | 31 participants | 59 participants |
| Diagnosis Graves disease | 13 participants | 12 participants | 25 participants |
| Histology of specimen Benign disease | 69 participants | 67 participants | 136 participants |
| Histology of specimen Follicular thyroid cancer (FTC) | 4 participants | 2 participants | 6 participants |
| Histology of specimen Papillary thyroid cancer (PTC) | 3 participants | 7 participants | 10 participants |
| Lymph node dissection (C1/level VI) no | 63 participants | 65 participants | 128 participants |
| Lymph node dissection (C1/level VI) yes | 13 participants | 11 participants | 24 participants |
| Operating time | 126.2 minutes STANDARD_DEVIATION 40.9 | 127.5 minutes STANDARD_DEVIATION 45.7 | 126.8 minutes STANDARD_DEVIATION 43.2 |
| Region of Enrollment Switzerland | 76 participants | 76 participants | 152 participants |
| Sex: Female, Male Female | 62 Participants | 58 Participants | 120 Participants |
| Sex: Female, Male Male | 14 Participants | 18 Participants | 32 Participants |
| Specimen weight | 45.3 gram STANDARD_DEVIATION 40.1 | 51.2 gram STANDARD_DEVIATION 58.2 | 48.3 gram STANDARD_DEVIATION 49.9 |
| Type of surgery Hemithyroidectomy | 37 participants | 38 participants | 75 participants |
| Type of surgery Near total thyroidectomy | 19 participants | 13 participants | 32 participants |
| Type of surgery Total thyroidectomy | 20 participants | 25 participants | 45 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 76 | 9 / 76 |
| serious Total, serious adverse events | 0 / 76 | 0 / 76 |
Outcome results
Primary
Incidence of Postoperative Nausea and Vomiting
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
Time frame: within 48 hours after surgery
Population: intention to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone Injection | Incidence of Postoperative Nausea and Vomiting | 29 percentage of participants |
| Placebo (NaCl 0.9%) | Incidence of Postoperative Nausea and Vomiting | 57 percentage of participants |
Comparison: null hypothesis: Incidence of PONV is the same in both treatment armsp-value: 0.00195% CI: [12, 42]Chi-squared
Secondary
Degree of Post Operative Nausea and Vomiting
mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event
Time frame: 4 hours after surgery
Population: intention to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexamethasone Injection | Degree of Post Operative Nausea and Vomiting | mild nausea | 9 participants |
| Dexamethasone Injection | Degree of Post Operative Nausea and Vomiting | severe nausea | 1 participants |
| Dexamethasone Injection | Degree of Post Operative Nausea and Vomiting | vomiting | 3 participants |
| Placebo (NaCl 0.9%) | Degree of Post Operative Nausea and Vomiting | mild nausea | 15 participants |
| Placebo (NaCl 0.9%) | Degree of Post Operative Nausea and Vomiting | severe nausea | 3 participants |
| Placebo (NaCl 0.9%) | Degree of Post Operative Nausea and Vomiting | vomiting | 12 participants |
Secondary
Degree of Post Operative Nausea and Vomiting
mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event
Time frame: 8 hours after surgery
Population: intention to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexamethasone Injection | Degree of Post Operative Nausea and Vomiting | severe nausea | 0 participants |
| Dexamethasone Injection | Degree of Post Operative Nausea and Vomiting | mild nausea | 5 participants |
| Dexamethasone Injection | Degree of Post Operative Nausea and Vomiting | vomiting | 8 participants |
| Placebo (NaCl 0.9%) | Degree of Post Operative Nausea and Vomiting | mild nausea | 7 participants |
| Placebo (NaCl 0.9%) | Degree of Post Operative Nausea and Vomiting | severe nausea | 3 participants |
| Placebo (NaCl 0.9%) | Degree of Post Operative Nausea and Vomiting | vomiting | 12 participants |
Secondary
Incidence of Postoperative Nausea and Vomiting
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
Time frame: within 48 hours after surgery (PP)
Population: per protocol analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone Injection | Incidence of Postoperative Nausea and Vomiting | 28 percentage of participants |
| Placebo (NaCl 0.9%) | Incidence of Postoperative Nausea and Vomiting | 52 percentage of participants |
Comparison: per protocol analysisp-value: 0.00695% CI: [7, 40]Chi-squared
Secondary
Length of Hospital Stay
Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group
Time frame: Difference between day of admission and day of discharge
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Injection | Length of Hospital Stay | 48.3 hour | Standard Deviation 15.7 |
| Placebo (NaCl 0.9%) | Length of Hospital Stay | 48.1 hour | Standard Deviation 12.6 |
p-value: 0.835Wilcoxon (Mann-Whitney)
Secondary
Necessary Anesthesiological Medication
Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group
Time frame: measured from beginning of anaesthesia to end of anaesthesia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Injection | Necessary Anesthesiological Medication | Propofol | 1097 milligram | Standard Deviation 422 |
| Dexamethasone Injection | Necessary Anesthesiological Medication | Fentanyl | 0.427 milligram | Standard Deviation 0.111 |
| Dexamethasone Injection | Necessary Anesthesiological Medication | Remifentanil | 1.944 milligram | Standard Deviation 1.197 |
| Dexamethasone Injection | Necessary Anesthesiological Medication | Rocuronium | 38.7 milligram | Standard Deviation 7.3 |
| Placebo (NaCl 0.9%) | Necessary Anesthesiological Medication | Remifentanil | 1.978 milligram | Standard Deviation 1.111 |
| Placebo (NaCl 0.9%) | Necessary Anesthesiological Medication | Propofol | 1168 milligram | Standard Deviation 422 |
| Placebo (NaCl 0.9%) | Necessary Anesthesiological Medication | Rocuronium | 39.7 milligram | Standard Deviation 8.3 |
| Placebo (NaCl 0.9%) | Necessary Anesthesiological Medication | Fentanyl | 0.444 milligram | Standard Deviation 0.108 |
Secondary
Postoperative Pain After Physical Stress
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)
Time frame: 4 and 8 hours after surgery
Population: intention to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Injection | Postoperative Pain After Physical Stress | 4 hours after surgery | 1.88 units on a scale | Standard Deviation 1.52 |
| Dexamethasone Injection | Postoperative Pain After Physical Stress | 8 hours after surgery | 1.88 units on a scale | Standard Deviation 1.54 |
| Placebo (NaCl 0.9%) | Postoperative Pain After Physical Stress | 4 hours after surgery | 2.09 units on a scale | Standard Deviation 1.73 |
| Placebo (NaCl 0.9%) | Postoperative Pain After Physical Stress | 8 hours after surgery | 2.01 units on a scale | Standard Deviation 1.75 |
p-value: 0.674Mixed Models Analysis