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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone injection | Active Comparator | Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) |
|
| Placebo (NaCl 0.9%) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| within 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Clerici, MD | Cantonal Hospital of St. Gallen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery | Sankt Gallen | 9007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25563879 | Derived | Tarantino I, Warschkow R, Beutner U, Kolb W, Luthi A, Luthi C, Schmied BM, Clerici T. Efficacy of a Single Preoperative Dexamethasone Dose to Prevent Nausea and Vomiting After Thyroidectomy (the tPONV Study): A Randomized, Double-blind, Placebo-controlled Clinical Trial. Ann Surg. 2015 Dec;262(6):934-40. doi: 10.1097/SLA.0000000000001112. | |
| 24015953 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Injection | Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery |
| FG001 | Placebo (NaCl 0.9%) | NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intention to Treat Analysis |
| |||||||||||||
| Per Protocol Analysis |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone Injection | Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery |
| BG001 | Placebo (NaCl 0.9%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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)
| intention to treat analysis | Posted | Number | 95% Confidence Interval | percentage of participants | within 48 hours after surgery |
|
during hospitalisation (on average 2 days)
adverse events were recorded during the hospital stay
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone Injection | Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| surgical adverse event grade I | Surgical and medical procedures | Clavien Dindo | Systematic Assessment | for example: recurrent laryngeal nerve palsy, hoarseness, minor bleeding |
all patients received a bilateral superficial cervical plexus block during surgery which could explain the very low postoperative pain scores compared to other similar studies
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ignazio Tarantino | Department of General, Abdominal and Transplant Surgery, University of Heidelberg | ignazio.tarantino@med.uni-heidelberg.de |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| NaCl 0.9% | Other | 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery |
|
| within 48 hours after surgery (PP) |
| 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 | 4 hours after surgery |
| 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 | 8 hours after surgery |
| Postoperative Pain After Physical Stress | Compare grade of pain between the treatment (dexamethasone) and the control (saline) group
| 4 and 8 hours after surgery |
| Length of Hospital Stay | Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group | Difference between day of admission and day of discharge |
| Necessary Anesthesiological Medication | Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group | measured from beginning of anaesthesia to end of anaesthesia |
| Tarantino I, Beutner U, Kolb W, Muller SA, Luthi C, Luthi A, Schmied BM, Clerici T, Warschkow R. Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study. BMC Anesthesiol. 2013 Sep 9;13(1):19. doi: 10.1186/1471-2253-13-19. |
| NOT COMPLETED |
|
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m² |
|
| Diagnosis | Number | participants |
|
| Type of surgery | Number | participants |
|
| Lymph node dissection (C1/level VI) | Number | participants |
|
| Operating time | Mean | Standard Deviation | minutes |
|
| Specimen weight | Mean | Standard Deviation | gram |
|
| Histology of specimen | Number | participants |
|
| Placebo (NaCl 0.9%) |
NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery |
|
|
|
| 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)
| per protocol analysis | Posted | Number | 95% Confidence Interval | percentage of participants | within 48 hours after surgery (PP) |
|
|
|
|
| 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 | intention to treat | Posted | Number | participants | 4 hours after surgery |
|
|
|
| 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 | intention to treat | Posted | Number | participants | 8 hours after surgery |
|
|
|
| Secondary | Postoperative Pain After Physical Stress | Compare grade of pain between the treatment (dexamethasone) and the control (saline) group
| intention to treat analysis | Posted | Mean | Standard Deviation | units on a scale | 4 and 8 hours after surgery |
|
|
|
|
| Secondary | Length of Hospital Stay | Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group | intention to treat | Posted | Mean | Standard Deviation | hour | Difference between day of admission and day of discharge |
|
|
|
|
| Secondary | Necessary Anesthesiological Medication | Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group | Posted | Mean | Standard Deviation | milligram | measured from beginning of anaesthesia to end of anaesthesia |
|
|
|
| 0 |
| 76 |
| 8 |
| 76 |
| EG001 | Placebo (NaCl 0.9%) | NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery | 0 | 76 | 9 | 76 |
|
| temporary hypoparathyroidism | Endocrine disorders | Clavien Dindo | Systematic Assessment | Grade 2 on Clavien-Dindo scale |
|
| bleeding requiring reoperation | Surgical and medical procedures | Systematic Assessment |
|
| medical adverse events grade 1 | General disorders | CTCAE | Systematic Assessment | for example: coughing, sinus tachycardia, temporary compensated renal insufficiency |
|
| Allergic reaction to metamizole | Immune system disorders | Systematic Assessment | CTCAE grade 2 |
|
| hypocalcemia | Endocrine disorders | Systematic Assessment | CTCAE grade 2 |
|
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| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| vomiting |
|
| vomiting |
|
| Fentanyl |
|
| Rocuronium |
|