Postoperative Nausea and Vomiting
Conditions
Brief summary
Dexamethasone is almost one of the most commonly used drugs for postoperative nausea and vomiting (PONV) prevention. However, PONV is still a complex problem to be solved; for example, even with preoperative dexamethasone administration, there are still some patients undergoing craniotomy still experience PONV within 24 hours postoperatively. Compared to dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, 2-5 times that of traditional water-soluble dexamethasone, with fewer adverse effects. This trial aims to assess the effect and safety of preoperative dexamethasone palmitate on PONV after craniotomy.
Interventions
DRUGDexamethasone
Patients in the dexamethasone group will be assigned to receive intravenous injections of dexamethasone 5 mg after anesthesia induction and before surgical incision.
Patients in the dexamethasone palmitate group will be assigned to receive intravenous injection of dexamethasone palmitate 8 mg (contains 5mg dexamethasone) after anesthesia induction and before surgical incision.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 to 65 years; * Providing written informed consent; * Perform elective craniotomy undergoing general anesthesia.
Exclusion criteria
* Known to be allergic to dexamethasone; * Any systemic glucocorticoids within 3 months before trial entry; * History of severe heart disease, liver/kidney failure, or systemic rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, et al); * Cognitive impairment or severe mental illness; * Uncontrolled diabetes or infectious diseases; * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of PONV | Within the first 24 hours postoperatively | PONV will be defined as any nausea, emetic episodes (vomiting or retching), or both. Nausea is defined as an unpleasant sensation with an urge to vomit. Vomiting is defined as the physical event of forcefully expelling gastric contents through the mouth. Retching refers to the forced movement of gastrointestinal contents without actual expulsion of vomitus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea (PON) and postoperative vomiting (POV) | At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively | Incidence of postoperative nausea (PON) and postoperative vomiting (POV) |
| The number of vomiting or retching episodes | Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively | The number of vomiting or retching episodes |
| The severity of PONV | At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively | The severity of PONV will be measured using the simplified PONV impact scoring system. The simplified PONV impact scoring system evaluates the nausea impact subscale and vomiting frequency score. Nausea impact subscale scoring will be rated by visual analogue scales (VAS) (0 = no impact to 10 = maximum impact). The VAS scores will be converted to 0-3 points via predefined thresholds. The Vomiting Frequency Score is categorized as follows: 0 for no episodes, 1 for 1-2 episodes, 2 for 3-5 episodes, and 3 for 6 or more episodes. The total score is calculated as the sum of the VAS-derived nausea impact score and the vomiting frequency score |
| Participant satisfaction with PONV management | At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively | Participant satisfaction will be also rated by visual analogue scales (VAS) (0 = very dissatisfied to 10 = most satisfied imaginable). |
| The Incidence of PONV | At 6 hours, 48 hours, and 72 hours postoperatively | PONV will be defined as any nausea, emetic episodes (vomiting or retching), or both. Nausea is defined as an unpleasant sensation with an urge to vomit. Vomiting is defined as the physical event of forcefully expelling gastric contents through the mouth. Retching refers to the forced movement of gastrointestinal contents without actual expulsion of vomitus. |
| The quality of postoperative recovery (QoR) | At 24 and 48 hours postoperatively, discharge, and 1 month postoperatively | The quality of postoperative recovery (QoR) will be assessed by the 15-item quality of recovery scoring system \[QoR-15\] |
| The VAS scale | At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively | The VAS scale (0 = no pain to 10 = maximum pain) |
| Postoperative length of stay (LOS) | Within 1 month postoperatively | Postoperative length of stay (LOS) |
| Safety outcomes | Within 1 month postoperatively | Such as hypotension, bradycardia, hypertension, tachycardia, et al. |
| The use of rescue antiemetic drugs | During the 0-24 hours, 24-48 hours, and 48-72 hours postoperatively | The use of rescue antiemetic drugs |
Countries
China
Contacts
Primary ContactFang Luo
Outcome results
None listed