Postoperative Nausea and Vomiting
Conditions
Keywords
Postoperative nausea vomiting, Efficacy, Palanosetron, Dexamethason, Gynaecological laparoscopic surgery
Brief summary
Postoperative nausea and vomiting (PONV) is a common complication after general anaesthesia, especially among female patients undergoing laparoscopic surgery. This randomized controlled trial evaluates whether combined palonosetron and dexamethasone is more effective than palonosetron alone in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery. Eligible patients will be randomized into two parallel groups. The intervention group will receive palonosetron plus dexamethasone, while the comparator group will receive palonosetron alone. Patients will be followed for 24 hours after surgery for incidence and severity of nausea and vomiting, rescue antiemetic requirement, adverse effects, patient satisfaction, and haemodynamic parameters.
Detailed description
Postoperative nausea and vomiting (PONV) is a common and distressing complication following general anaesthesia, particularly among female patients undergoing laparoscopic surgical procedures. Although several medications are available for prevention of PONV, no single agent completely eliminates the risk because multiple physiological and surgical factors contribute to its development. Palonosetron is a second-generation serotonin (5-hydroxytryptamine-3 or 5-HT3) receptor antagonist with a prolonged duration of action and strong receptor affinity. It reduces nausea and vomiting by blocking serotonin-mediated pathways involved in the vomiting reflex. Dexamethasone, a corticosteroid with antiemetic properties, has also been shown to enhance the effectiveness of other antiemetic medications through multiple mechanisms, including modulation of inflammatory pathways and enhancement of antiemetic receptor sensitivity. This randomized controlled trial is designed to evaluate whether adding dexamethasone to palonosetron provides improved prevention of postoperative nausea and vomiting compared with palonosetron alone in patients undergoing gynaecological laparoscopic surgery under general anaesthesia. Participants will be randomly assigned to receive either combined palonosetron and dexamethasone or palonosetron alone before induction of anaesthesia. All participants will undergo standardized anaesthetic management and postoperative monitoring. The study will assess the effectiveness and safety of these preventive strategies during the postoperative period. The findings of this study may provide additional evidence regarding the role of combination antiemetic therapy in improving postoperative recovery, patient comfort, and satisfaction after laparoscopic gynaecological procedures. The results may contribute to optimizing perioperative care practices and improving the management of patients at risk of postoperative nausea and vomiting.
Interventions
DRUGPalonosetron and Dexamethason
Participants receive palonosetron 0.075 mg IV combined with dexamethasone 5 mg IV before induction of general anaesthesia.
DRUGPalonosetron
Participants receive palonosetron 0.075 mg IV before induction of general anaesthesia.
Sponsors
Bangladesh Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing gynaecological laparoscopic surgery * ASA physical status I and II * Age 20-40 years * Provided informed consent
Exclusion criteria
* Pregnancy * Menstruation * Gastroesophageal reflux disease * BMI \>35 kg/m² * Allergy or contraindication to study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting | 24 hours after surgery | Occurrence of nausea and vomiting episodes during the postoperative period (0-24 hours). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of postoperative nausea and vomiting | 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery | Severity of nausea and vomiting will be assessed using the Visual Analogue Scale (VAS), where 0 indicates no nausea and 10 indicates the worst possible nausea. The severity will be evaluated and compared between the two study groups during the postoperative period. |
| Requirement of rescue antiemetic medication | During the first 24 hours after surgery | The requirement for rescue antiemetic medication will be recorded and compared between groups. Patients experiencing significant nausea or vomiting (VAS score ≥4) will receive rescue antiemetic treatment with intravenous metoclopramide 10 mg, and the total requirement will be documented. |
| Incidence of adverse effects related to study drugs | During the first 24 hours after surgery | Drug-related adverse effects, including dizziness, headache, and arrhythmia, will be monitored and compared between the study groups using a four-point severity scale. |
| Patient satisfaction after surgery | At 24 hours after surgery | Patient satisfaction regarding postoperative recovery and nausea-vomiting management will be assessed using a 5-point Likert satisfaction scale, where 1 indicates very dissatisfied, and 5 indicates very satisfied. Higher scores indicate greater patient satisfaction. The satisfaction scores will be compared between the two study groups. |
| Postoperative systolic blood pressure (SBP) | At 1, 6, 12, and 24 hours after surgery | Systolic blood pressure will be measured and compared between the palonosetron-dexamethasone group and the palonosetron alone group during the postoperative period. |
| Postoperative diastolic blood pressure (DBP) | At 1, 6, 12, and 24 hours after surgery | Diastolic blood pressure will be measured and compared between the study groups during postoperative follow-up. |
| Postoperative mean arterial pressure (MAP) | At 1, 6, 12, and 24 hours after surgery | Mean arterial pressure will be recorded and compared between the two study groups during the postoperative period. |
| Postoperative heart rate (HR) | At 1, 6, 12, and 24 hours after surgery | Heart rate will be monitored and compared between the palonosetron-dexamethasone group and the palonosetron alone group after surgery. |
| Postoperative oxygen saturation (SpO₂) | At 1, 6, 12, and 24 hours after surgery | Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and compared between the two study groups during postoperative follow-up. |
Countries
Bangladesh
Contacts
STUDY_DIRECTORAKM Akhtaruzzaman, MD
Bangladesh Medical University
Outcome results
None listed