Postoperative Nausea and VomitingPhase 4NCT07813897
Efficacy of Palonosetron Plus Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Gynaecological Laparoscopic Surgery
A Phase 4 study testing Palonosetron and Dexamethason and Palonosetron in people with Postoperative Nausea and Vomiting, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Palonosetron and Dexamethason and Palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBangladesh
- Study dates
- 10 Sep 2025to 30 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing gynaecological laparoscopic surgery
- ASA physical status I and II
- Age 20-40 years
- Provided informed consent
Who cannot join
- Pregnancy
- Menstruation
- Gastroesophageal reflux disease
- BMI >35 kg/m²
- Allergy or contraindication to study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combined Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Patients Undergoing 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Palonosetron and Dexamethason, Palonosetron
- Keywords
- Postoperative nausea vomiting, Efficacy, Palanosetron, Dexamethason, Gynaecological laparoscopic surgery
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palonosetron and DexamethasonDrug
Participants receive palonosetron 0.075 mg IV combined with dexamethasone 5 mg IV before induction of general anaesthesia.
PalonosetronDrug
Participants receive palonosetron 0.075 mg IV before induction of general anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron and Dexamethasone | Experimental | Participants receive palonosetron 0.075 mg IV combined with dexamethasone 5 mg IV before induction of general anaesthesia. Receives: Drug: Palonosetron and Dexamethason |
| .Palanosetron alone | Active comparator | Participants receive palonosetron 0.075 mg IV before induction of general anaesthesia Receives: Drug: Palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting
Occurrence of nausea and vomiting episodes during the postoperative period (0-24 hours).
Measured: 24 hours after surgery
Secondary outcomes (9)
Severity of postoperative nausea and vomiting
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.
Measured: 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery
Requirement of rescue antiemetic medication
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.
Measured: During the first 24 hours after surgery
Incidence of adverse effects related to study drugs
Drug-related adverse effects, including dizziness, headache, and arrhythmia, will be monitored and compared between the study groups using a four-point severity scale.
Measured: During the first 24 hours after surgery
Patient satisfaction 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.
Measured: At 24 hours after surgery
Postoperative systolic blood pressure (SBP)
Systolic blood pressure will be measured and compared between the palonosetron-dexamethasone group and the palonosetron alone group during the postoperative period.
Measured: At 1, 6, 12, and 24 hours after surgery
Postoperative diastolic blood pressure (DBP)
Diastolic blood pressure will be measured and compared between the study groups during postoperative follow-up.
Measured: At 1, 6, 12, and 24 hours after surgery
Postoperative mean arterial pressure (MAP)
Mean arterial pressure will be recorded and compared between the two study groups during the postoperative period.
Measured: At 1, 6, 12, and 24 hours after surgery
Postoperative heart rate (HR)
Heart rate will be monitored and compared between the palonosetron-dexamethasone group and the palonosetron alone group after surgery.
Measured: At 1, 6, 12, and 24 hours after surgery
Postoperative oxygen saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and compared between the two study groups during postoperative follow-up.
Measured: At 1, 6, 12, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start10 Sep 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazi Mahzabin Arin, Bangladesh Medical University
- Investigators
- AKM Akhtaruzzaman, MD, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813897
- Sponsor's protocol ID
- BSMMU/2025/12379
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho E, Kim DH, Shin S, Kim SH, Oh YJ, Choi YS. Efficacy of Palonosetron-Dexamethasone Combination Versus Palonosetron Alone for Preventing Nausea and Vomiting Related to Opioid-Based Analgesia: A Prospective, Randomized, Double-blind Trial. Int J Med Sci. 2018 Jun 13;15(10):961-968. doi: 10.7150/ijms.24230. eCollection 2018.
PubMed 30013436Minkowitz H, Leiman D, Lu L, Reines S, Ryan M, Harnett M, Singla N. IV Tramadol - A New Treatment Option for Management of Post-Operative Pain in the US: An Open-Label, Single-Arm, Safety Trial Including Various Types of Surgery. J Pain Res. 2020 May 22;13:1155-1162. doi: 10.2147/JPR.S251175. eCollection 2020.
PubMed 32547178Ryoo SH, Yoo JH, Kim MG, Lee KH, Kim SI. The effect of combination treatment using palonosetron and dexamethasone for the prevention of postoperative nausea and vomiting versus dexamethasone alone in women receiving intravenous patient-controlled analgesia. Korean J Anesthesiol. 2015 Jun;68(3):267-73. doi: 10.4097/kjae.2015.68.3.267. Epub 2015 May 28.
PubMed 26045930Bala I, Bharti N, Murugesan S, Gupta R. Comparison of palonosetron with palonosetron-dexamethasone combination for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Minerva Anestesiol. 2014 Jul;80(7):779-84. Epub 2013 Nov 26.
PubMed 24280811Ho CM, Wu HL, Ho ST, Wang JJ. Dexamethasone prevents postoperative nausea and vomiting: benefit versus risk. Acta Anaesthesiol Taiwan. 2011 Sep;49(3):100-4. doi: 10.1016/j.aat.2011.06.002.
PubMed 21982171Park SK, Cho EJ. A randomized, double-blind trial of palonosetron compared with ondansetron in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery. J Int Med Res. 2011;39(2):399-407. doi: 10.1177/147323001103900207.
PubMed 21672343Laha B, Hazra A, Mallick S. Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: a randomized controlled trial. Indian J Pharmacol. 2013 Jan-Feb;45(1):24-9. doi: 10.4103/0253-7613.106430.
PubMed 23543732Balyan R, Kumar S, Lalitha K, Aneja S, George J. A Randomised Study To Compare Palonosetron With Ondansetron for Prophylaxis of Postoperative Nausea and Vomiting (PONV) Following Laparoscopic Gynecological Surgeries. Cureus. 2022 Mar 29;14(3):e23615. doi: 10.7759/cureus.23615. eCollection 2022 Mar.
PubMed 35505760Kim SH, Hong JY, Kim WO, Kil HK, Karm MH, Hwang JH. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study. Korean J Anesthesiol. 2013 Jun;64(6):517-23. doi: 10.4097/kjae.2013.64.6.517. Epub 2013 Jun 24.
PubMed 23814652Xu H, Rong L, Yang S, Xing J, Dong H, Liu H, Chen X, Liu L. 5-HT3 receptor antagonists for preventing postoperative nausea and vomiting after gynecological surgery: A systematic review and network meta-analysis. Int J Gynaecol Obstet. 2025 Oct;171(1):177-189. doi: 10.1002/ijgo.70197. Epub 2025 May 9.
PubMed 40348596Reddy GS, Manjusruthi B, Jyothsna G. Postoperative Nausea and Vomiting Prophylaxis: A Comparative Study of Ramosetron and Palonosetron in Patients Undergoing Laparoscopic Cholecystectomy - A Prospective Randomized Trial. Anesth Essays Res. 2019 Jan-Mar;13(1):68-72. doi: 10.4103/aer.AER_192_18.
PubMed 31031483Khan MA, Gupta A, Gupta N, Mitra M. Efficacy of Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomised Double-Blind Trial. Turk J Anaesthesiol Reanim. 2021 Oct;49(5):400-406. doi: 10.5152/TJAR.2021.191.
PubMed 35110042Lal B, Alagarsamy R, Kumar J, Rai AJ, Yadav V, Joshi R, Yunus M. Comparison of efficacy and safety between palonosetron and ondansetron to prevent postoperative nausea and vomiting in patients undergoing non-laparoscopic surgery: A systematic review and meta-analysis of randomised controlled trials. Indian J Anaesth. 2025 Jan;69(1):108-122. doi: 10.4103/ija.ija_1017_24. Epub 2025 Jan 11.
PubMed 40046699Sharma AN, Shankaranarayana P. Postoperative Nausea and Vomiting: Palonosetron with Dexamethasone vs. Ondansetron with Dexamethasone in Laparoscopic Hysterectomies. Oman Med J. 2015 Jul;30(4):252-6. doi: 10.5001/omj.2015.51.
PubMed 26366258Dey S, Chanu SM, Dev P, Borthakur M, Karim HMR, Yunus M. Antiemetic Efficacy of Palonosetron Compared with the Combination of Ondansetron and Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynaecological Surgery. Rom J Anaesth Intensive Care. 2022 Sep 25;28(1):19-24. doi: 10.2478/rjaic-2021-0003. eCollection 2021 Jul.
PubMed 36846536
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Gynaecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07813897
- Acronym / sponsor ID
- BSMMU/2025/12379
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative nausea vomiting, Efficacy, Palanosetron, Dexamethason, Gynaecological laparoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palonosetron and Dexamethasone | Experimental | Drug: Palonosetron and DexamethasonParticipants receive palonosetron 0.075 mg IV combined with dexamethasone 5 mg IV before induction of general anaesthesia. |
| .Palanosetron alone | Active comparator | Drug: PalonosetronParticipants receive palonosetron 0.075 mg IV before induction of general anaesthesia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients undergoing gynaecological laparoscopic surgery
- ASA physical status I and II
- Age 20-40 years
- Provided informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Menstruation
- Gastroesophageal reflux disease
- BMI >35 kg/m²
- Allergy or contraindication to study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palonosetron and DexamethasonParticipants receive palonosetron 0.075 mg IV combined with dexamethasone 5 mg IV before induction of general anaesthesia. | Drug | Palonosetron and Dexamethasone |
| PalonosetronParticipants receive palonosetron 0.075 mg IV before induction of general anaesthesia. | Drug | .Palanosetron alone |
Primary outcome
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).
9 secondary outcomes
Severity of postoperative nausea and vomiting
Time frame: 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery
Requirement of rescue antiemetic medication
Time frame: During the first 24 hours after surgery
Incidence of adverse effects related to study drugs
Time frame: During the first 24 hours after surgery
Patient satisfaction after surgery
Time frame: At 24 hours after surgery
Postoperative systolic blood pressure (SBP)
Time frame: At 1, 6, 12, and 24 hours after surgery
Postoperative diastolic blood pressure (DBP)
Time frame: At 1, 6, 12, and 24 hours after surgery
Postoperative mean arterial pressure (MAP)
Time frame: At 1, 6, 12, and 24 hours after surgery
Postoperative heart rate (HR)
Time frame: At 1, 6, 12, and 24 hours after surgery
Postoperative oxygen saturation (SpO₂)
Time frame: At 1, 6, 12, and 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 30013436Cho E, Kim DH, Shin S, Kim SH, Oh YJ, Choi YS. Efficacy of Palonosetron-Dexamethasone Combination Versus Palonosetron Alone for Preventing Nausea and Vomiting Related to Opioid-Based Analgesia: A Prospective, Randomized, Double-blind Trial. Int J Med Sci. 2018 Jun 13;15(10):961-968. doi: 10.7150/ijms.24230. eCollection 2018.
- Background: PubMed 32547178Minkowitz H, Leiman D, Lu L, Reines S, Ryan M, Harnett M, Singla N. IV Tramadol - A New Treatment Option for Management of Post-Operative Pain in the US: An Open-Label, Single-Arm, Safety Trial Including Various Types of Surgery. J Pain Res. 2020 May 22;13:1155-1162. doi: 10.2147/JPR.S251175. eCollection 2020.
- Background: PubMed 26045930Ryoo SH, Yoo JH, Kim MG, Lee KH, Kim SI. The effect of combination treatment using palonosetron and dexamethasone for the prevention of postoperative nausea and vomiting versus dexamethasone alone in women receiving intravenous patient-controlled analgesia. Korean J Anesthesiol. 2015 Jun;68(3):267-73. doi: 10.4097/kjae.2015.68.3.267. Epub 2015 May 28.
- Background: PubMed 24280811Bala I, Bharti N, Murugesan S, Gupta R. Comparison of palonosetron with palonosetron-dexamethasone combination for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Minerva Anestesiol. 2014 Jul;80(7):779-84. Epub 2013 Nov 26.
- Background: PubMed 21982171Ho CM, Wu HL, Ho ST, Wang JJ. Dexamethasone prevents postoperative nausea and vomiting: benefit versus risk. Acta Anaesthesiol Taiwan. 2011 Sep;49(3):100-4. doi: 10.1016/j.aat.2011.06.002.
- Background: PubMed 21672343Park SK, Cho EJ. A randomized, double-blind trial of palonosetron compared with ondansetron in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery. J Int Med Res. 2011;39(2):399-407. doi: 10.1177/147323001103900207.
- Background: PubMed 23543732Laha B, Hazra A, Mallick S. Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: a randomized controlled trial. Indian J Pharmacol. 2013 Jan-Feb;45(1):24-9. doi: 10.4103/0253-7613.106430.
- Background: PubMed 35505760Balyan R, Kumar S, Lalitha K, Aneja S, George J. A Randomised Study To Compare Palonosetron With Ondansetron for Prophylaxis of Postoperative Nausea and Vomiting (PONV) Following Laparoscopic Gynecological Surgeries. Cureus. 2022 Mar 29;14(3):e23615. doi: 10.7759/cureus.23615. eCollection 2022 Mar.
- Background: PubMed 23814652Kim SH, Hong JY, Kim WO, Kil HK, Karm MH, Hwang JH. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study. Korean J Anesthesiol. 2013 Jun;64(6):517-23. doi: 10.4097/kjae.2013.64.6.517. Epub 2013 Jun 24.
- Background: PubMed 40348596Xu H, Rong L, Yang S, Xing J, Dong H, Liu H, Chen X, Liu L. 5-HT3 receptor antagonists for preventing postoperative nausea and vomiting after gynecological surgery: A systematic review and network meta-analysis. Int J Gynaecol Obstet. 2025 Oct;171(1):177-189. doi: 10.1002/ijgo.70197. Epub 2025 May 9.
- Background: PubMed 31031483Reddy GS, Manjusruthi B, Jyothsna G. Postoperative Nausea and Vomiting Prophylaxis: A Comparative Study of Ramosetron and Palonosetron in Patients Undergoing Laparoscopic Cholecystectomy - A Prospective Randomized Trial. Anesth Essays Res. 2019 Jan-Mar;13(1):68-72. doi: 10.4103/aer.AER_192_18.
- Background: PubMed 35110042Khan MA, Gupta A, Gupta N, Mitra M. Efficacy of Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomised Double-Blind Trial. Turk J Anaesthesiol Reanim. 2021 Oct;49(5):400-406. doi: 10.5152/TJAR.2021.191.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AKM Akhtaruzzaman, MD study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Palonosetron and Dexamethason and Palonosetron in people with Postoperative Nausea and Vomiting, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813897, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.