Postoperative Vomiting
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERGroup 1
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.
OTHERGroup 2
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.
Sponsors
Aydin Adnan Menderes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
ASA physical status I or II * Age 2-15 yr * Scheduled for elective tonsillectomy and/or adenotonsillectomy
Exclusion criteria
* History of diabetes * History of mental retardation * Obesity (BMI = \> 95th percentile for age and sex) * Intake of antiemetic or psychoactive medication within 24 hours before surgery * Known gastroesophageal reflux
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Vomiting | First 24 hours postoperative | Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Intravenous 10 ml/kg/h 0.9% saline solution | 80 |
| Group 2 Intravenous 20 ml/kg/h 0.9% saline solution | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | Group 2 | Total | Group 1 |
|---|---|---|---|
| Age, Categorical <=18 years | 80 Participants | 160 Participants | 80 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Turkey | 80 participants | 160 participants | 80 participants |
| Sex: Female, Male Female | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Male | 40 Participants | 80 Participants | 40 Participants |
| Supplemental fluid administration for vomiting | 80 participants | 160 participants | 80 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
Primary
Postoperative Vomiting
Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition
Time frame: First 24 hours postoperative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10 ml/kg/h 0.9 %Saline Solution | Postoperative Vomiting | vomiting | 11 participants |
| 10 ml/kg/h 0.9 %Saline Solution | Postoperative Vomiting | not vomiting | 66 participants |
| 20 ml/kg/h 0.9% Saline Solution | Postoperative Vomiting | vomiting | 9 participants |
| 20 ml/kg/h 0.9% Saline Solution | Postoperative Vomiting | not vomiting | 68 participants |
Comparison: Null hypothesis: The antiemetic effect was not significantly different for two groups in this studyp-value: 0.05t-test, 2 sided
Comparison: 77 patients was needed in each groups for an 20% effect size, 5% alpha and 80% statistical power for postoperative vomiting.p-value: <0.05Chi-squared, Corrected