Postoperative Nausea and Vomiting
Conditions
Brief summary
Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.
Detailed description
Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.
Interventions
DRUGDexmedetomidine
administration of dexmedetomidine only
DRUGDexmedetomidine and dexamethasone
administration of dexmedetomidine and dexamethasone
DRUGControl
administration of normal saline
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.
Exclusion criteria
* uncontrolled cardiovascular disease * history of chronic pain * smoker * previous history of steroid administraion * neoajuvant chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea (Numeric Rating Scale for Nausea) | Changes from baseline in postoperative nausea at 30 min | Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea \>5 points on the numeric rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Vomiting (Number of Participants With Vomiting) | Changes from baseline in postoperative nausea at 30 min | frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively |
| Rhodes Index Score | assessed at 6 and 24 hour after operative end | Rhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0\ 4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome |
Participant flow
Pre-assignment details
There was no one who excluded before assignment to groups
Participants by arm
| Arm | Count |
|---|---|
| Control administration of 0.9% normal saline 10ml
Control: administration of normal saline | 50 |
| Dexmedetomidine administration of 0.5ug/kg of dexmedetomidine (5ml)
Dexmedetomidine: administration of dexmedetomidine only | 50 |
| Dexmedetomidine and Dexamethasone administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Dexmedetomidine | Dexmedetomidine and Dexamethasone | Total |
|---|---|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 6.4 | 48.2 years STANDARD_DEVIATION 7.1 | 48.4 years STANDARD_DEVIATION 7.5 | 48.5 years STANDARD_DEVIATION 7 |
| Region of Enrollment South Korea | 50 participants | 50 participants | 50 participants | 150 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 50 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Postoperative Nausea (Numeric Rating Scale for Nausea)
Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea \>5 points on the numeric rating scale
Time frame: Changes from baseline in postoperative nausea at 30 min
Population: Patients who underwent breast cancer surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Postoperative Nausea (Numeric Rating Scale for Nausea) | 0 scores on a scale |
| Dexmedetomidine | Postoperative Nausea (Numeric Rating Scale for Nausea) | 0 scores on a scale |
| Dexmedetomidine and Dexamethasone | Postoperative Nausea (Numeric Rating Scale for Nausea) | 0 scores on a scale |
Secondary
Postoperative Vomiting (Number of Participants With Vomiting)
frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively
Time frame: Changes from baseline in postoperative nausea at 30 min
Population: Patients who underwent breast cancer surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Postoperative Vomiting (Number of Participants With Vomiting) | 1-6 hour | 15 participants |
| Control | Postoperative Vomiting (Number of Participants With Vomiting) | 0-1 hour | 4 participants |
| Control | Postoperative Vomiting (Number of Participants With Vomiting) | 6-24hour | 9 participants |
| Dexmedetomidine | Postoperative Vomiting (Number of Participants With Vomiting) | 1-6 hour | 6 participants |
| Dexmedetomidine | Postoperative Vomiting (Number of Participants With Vomiting) | 0-1 hour | 0 participants |
| Dexmedetomidine | Postoperative Vomiting (Number of Participants With Vomiting) | 6-24hour | 5 participants |
| Dexmedetomidine and Dexamethasone | Postoperative Vomiting (Number of Participants With Vomiting) | 0-1 hour | 0 participants |
| Dexmedetomidine and Dexamethasone | Postoperative Vomiting (Number of Participants With Vomiting) | 6-24hour | 1 participants |
| Dexmedetomidine and Dexamethasone | Postoperative Vomiting (Number of Participants With Vomiting) | 1-6 hour | 1 participants |
Secondary
Rhodes Index Score
Rhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0\ 4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome
Time frame: assessed at 6 and 24 hour after operative end
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Rhodes Index Score | 1-6 hour after surgery | 5 score on a scale |
| Control | Rhodes Index Score | 6-24 hour after surgery | 3.5 score on a scale |
| Dexmedetomidine | Rhodes Index Score | 1-6 hour after surgery | 0 score on a scale |
| Dexmedetomidine | Rhodes Index Score | 6-24 hour after surgery | 0 score on a scale |
| Dexmedetomidine and Dexamethasone | Rhodes Index Score | 1-6 hour after surgery | 0 score on a scale |
| Dexmedetomidine and Dexamethasone | Rhodes Index Score | 6-24 hour after surgery | 0 score on a scale |