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Completed

NCT Number: NCT07813897

Efficacy of Palonosetron Plus Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Gynaecological Laparoscopic Surgery

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Bangladesh Medical University

Dhaka, 100, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palonosetron and Dexamethason

Drug

Participants receive palonosetron 0.075 mg IV combined with dexamethasone 5 mg IV before induction of general anaesthesia.

Palonosetron

Drug

Participants receive palonosetron 0.075 mg IV before induction of general anaesthesia.

Primary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: 24 hours after surgery

    Occurrence of nausea and vomiting episodes during the postoperative period (0-24 hours).

Secondary outcomes

  1. Severity of postoperative nausea and vomiting

    Time frame: 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.

  2. Requirement of rescue antiemetic medication

    Time frame: 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.

  3. Incidence of adverse effects related to study drugs

    Time frame: 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.

  4. Patient satisfaction after surgery

    Time frame: 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.

  5. Postoperative systolic blood pressure (SBP)

    Time frame: 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.

  6. Postoperative diastolic blood pressure (DBP)

    Time frame: 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.

  7. Postoperative mean arterial pressure (MAP)

    Time frame: 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.

  8. Postoperative heart rate (HR)

    Time frame: 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.

  9. Postoperative oxygen saturation (SpO₂)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

Efficacy of Combined Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Gynaecological Laparoscopic Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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