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Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of super-hydration with 0.9% saline in children undergoing specifically elective otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended period of fasting that interrupts the perfusion in gut. Based on this knowledge, we hypothesized that administration of supplemental fluid would reduce the incidence of postoperative vomiting.
At the initiation of the study, 160 patients we enrolled consecutively . Six of the patients were excluded according to the inclusion/exclusion criteria. Remaining one hundred fifty four were American Society of Anesthesia (ASA) I-II classified children , aged 2-15 yr, undergoing elective tonsillectomy, with or without adenoidectomy, under general anesthesia . Induction and maintenance of anesthesia were standardized with fentanyl, lidocaine, rocuronium and sevoflurane in nitrous oxide (N(2)O). Subjects were assigned to two groups administered with saline solution (%0.9 saline) at different rates; either 10 ml/kg/h or 20ml/kg/h delivery arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Sham Comparator | intravenous administration of 10 ml/kg/h 0.9% saline solution |
|
| Group 2 | Active Comparator | intravenous administration of 20 ml/kg/h 0.9% saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 | Other | Intravenous access was established and 10 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Vomiting | Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition | First 24 hours postoperative |
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Inclusion Criteria:ASA physical status I or II
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SÄ°NAN YILMAZ, MD | Adnan Menderes University,Faculty of Medicine, Department of Anesthesia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adnan Menderes University Training and Research Hospital | Aydin | Aydın | 09100 | Turkey (Türkiye) | ||
| Adnan Menders University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Intravenous 10 ml/kg/h 0.9% saline solution |
| FG001 | Group 2 | Intravenous 20 ml/kg/h 0.9% saline solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Intravenous 10 ml/kg/h 0.9% saline solution |
| BG001 | Group 2 | Intravenous 20 ml/kg/h 0.9% saline solution |
| 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 | Postoperative Vomiting | Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition | Posted | Number | participants | First 24 hours postoperative |
|
No adverse event were detected for all participants in the first 24 hours.
No adverse event were detected for all participants in the first 24 hours.
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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 | Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution | Group 1, intravenous 10 ml/kg/h 0.9% saline solution , After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sinan Yılmaz | Adnan Menders University, Anesthesiology and Reanimation Department | +905055954374 | dr_snnylmz@hotmail.com |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| Group 2 | Other | Intravenous access was established and 20 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation. |
|
| Aydin |
| 09100 |
| Turkey (Türkiye) |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Supplemental fluid administration for vomiting | Number | participants |
|
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution | Group 2, intravenous 20 ml/kg/h 0.9% saline solution. After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed. | 0 | 77 | 0 | 77 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |