Conditions: Gynecological Disease
Keywords: non-smoker female IV PCA patient-controlled analgesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: yes

Brief summary:
Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk PONV patients receiving intravenous patient-controlled anesthesia (IV PCA) after gynecological laparoscopic surgery.

Detailed description:
Female adults with three established PONV risk factors based on Apfel's score were randomised into one of three study groups. At the end of anaesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone during the induction of anaesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanaesthesia care unit (PACU).

Arms:
arm 1: dexamethasone 5mg iv during anesthesia induction arm 2: dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia arm 3: dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia

Interventions: intervention 1: Dexamethasone iv injection intervention 2: Dexamethasone, haloperidol intervention 3: Dexamethasone, haloperidol
Intervention descriptions: intervention 1: Dexamethasone 5mg iv during anesthesia induction intervention 2: dexamethasone + haloperidol 1mg intervention 3: Active Comparator: dexamethasone + haloperidol 2mg

Protocol document: