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 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 open surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
500
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.
Patients in the dexamethasone group will be assigned to receive intravenous injections of dexamethasone 5 mg after anesthesia induction and before surgical incision.
Fang Luo
Beijing, China
RECRUITINGThe incidence of PONV
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.
Time frame: Within the first 24 hours postoperatively
The Incidence of PONV
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.
Time frame: At 6 hours, 48 hours, and 72 hours postoperatively
Incidence of postoperative nausea (PON) and postoperative vomiting (POV)
Incidence of postoperative nausea (PON) and postoperative vomiting (POV)
Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
The number of vomiting or retching episodes
The number of vomiting or retching episodes
Time frame: Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
The severity of PONV
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.
Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
Participant satisfaction with PONV management
Participant satisfaction will be also rated by visual analogue scales (VAS) (0 = very dissatisfied to 10 = most satisfied imaginable)
Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
The use of rescue antiemetic drugs
The use of rescue antiemetic drugs (frequency, total intake amount, and type)
Time frame: During the 0-24 hours, 24-48 hours, and 48-72 hours postoperatively
The quality of postoperative recovery (QoR)
The quality of postoperative recovery (QoR) will be assessed by the 15-item quality of recovery scoring system \[QoR-15\]
Time frame: At 24 and 48 hours postoperatively; At discharge; At 1 month postoperatively
The VAS scale
The VAS scale (0 = no pain to 10 = maximum pain)
Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
Postoperative length of stay (LOS)
Postoperative length of stay (LOS)
Time frame: Within one month after surgery
Safety outcomes
Such as hypotension, bradycardia, hypertension, tachycardia, et al.
Time frame: Within one month after surgery
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