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| ID | Type | Description | Link |
|---|---|---|---|
| Patel Hospial | Other Identifier | Patel Hospital |
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Postoperative nausea and vomiting (PONV) remains a common and distressing complication after laparoscopic cholecystectomy despite advances in anesthesia. Both dexmedetomidine and dexamethasone have shown antiemetic properties, but their comparative effectiveness is still debated. To compare the efficacy of dexmedetomidine and dexamethasone in preventing PONV in patients undergoing laparoscopic cholecystectomy.
This double-blind randomized controlled trial included 68 ASA I-II patients scheduled for elective laparoscopic cholecystectomy. Patients were randomly allocated to receive either intravenous dexmedetomidine (1 μg/kg) or dexamethasone (8 mg) after induction of anesthesia. PONV was assessed using a standardized scoring system on arrival in the PACU and at 4, 12, and 24 hours postoperatively. Ondansetron was administered as rescue antiemetic when required.
This study aims to determine the more effective prophylactic agent for PONV, with the goal of improving postoperative comfort and quality of care in patients undergoing laparoscopic surgery in the local population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | Intravenous dexmedetomidine administered perioperatively for prevention of postoperative nausea and vomiting. |
|
| Dexmathasone group | Active Comparator | Intravenous dexamethasone administered perioperatively for prevention of postoperative nausea and vomiting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamedomedine | Drug | Intravenous dexmedetomidine administered perioperatively. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The PONV scores over the 24-hour period | PONV will be assessed using the Postoperative Nausea and Vomiting (PONV) Scoring Scale (range: 0-3; higher scores indicate worse outcome, where 0 = no nausea/vomiting and 3 = vomiting ≥3 episodes/day). Assessments will be performed at predefined time points: upon arrival in PACU (0 hours), 4 hours, 12 hours, and 24 hours postoperatively. | From arrival in the post-anesthesia care unit (0 hours) through 24 hours after surgery, assessed at 0, 4, 12, and 24 hours postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marium Rafiq | Karachi | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 12. Bajaj V, Singh S, Sharma R, Taank P, Dwivedi D. Effect of palonosetron monotherapy versus palonosetron with dexamethasone combination therapy for prevention of post operative nausea vomiting in children undergoing strabismus surgery. Int J Biomed Res. 2019 Feb 14;10(2):e5080 | ||
| 26045928 | Background | Bakri MH, Ismail EA, Ibrahim A. Comparison of dexmedetomidine and dexamethasone for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Korean J Anesthesiol. 2015 Jun;68(3):254-60. doi: 10.4097/kjae.2015.68.3.254. Epub 2015 May 28. | |
| Background | 10. Khadka B, Sharma NR. A Prospective comparative study of dexmedetomidine and dexamethasone for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. J Soc anesthesiol Nepal. 2021 Jul 5;8(1):e307. | ||
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IPD will not be shared due to ethical restrictions on sensitive patient information.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2026 |
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| Dexamethasone |
| Drug |
Intravenous dexamethasone administered perioperatively. |
|
| Background |
| Gul G, Bilgic T, Aydin MA. Evaluation of the Effects of Preoperative Dexamethasone Administration on Postoperative Patient Comfort in Laparoscopic Cholecystectomy. Cureus. 2020 May 5;12(5):e7968. doi: 10.7759/cureus.7968. |
| 36600843 | Background | Jamil K, Qaisar R. The Effect of Dexamethasone on Postoperative Pain in Patients After Laparoscopic Cholecystectomy. Cureus. 2022 Nov 30;14(11):e32067. doi: 10.7759/cureus.32067. eCollection 2022 Nov. |
| Background | 7. Masoori TA, Gupta K, Agarwal S, Bansal M, Zuberi A, Samad A. Clinical efficacy of dexmedetomidine in two different doses to attenuate the hemodynamic changes during laparoscopic cholecystectomy. Int J Res Med Sci. 2018 Mar;6:959-65. |
| 28072722 | Background | Jin S, Liang DD, Chen C, Zhang M, Wang J. Dexmedetomidine prevent postoperative nausea and vomiting on patients during general anesthesia: A PRISMA-compliant meta analysis of randomized controlled trials. Medicine (Baltimore). 2017 Jan;96(1):e5770. doi: 10.1097/MD.0000000000005770. |
| 33288117 | Background | Stoops S, Kovac A. New insights into the pathophysiology and risk factors for PONV. Best Pract Res Clin Anaesthesiol. 2020 Dec;34(4):667-679. doi: 10.1016/j.bpa.2020.06.001. Epub 2020 Jun 10. |
| 36147426 | Background | Sinha V, Vivekanand D, Singh S. Prevalence and risk factors of post-operative nausea and vomiting in a tertiary-care hospital: A cross-sectional observational study. Med J Armed Forces India. 2022 Sep;78(Suppl 1):S158-S162. doi: 10.1016/j.mjafi.2020.10.024. Epub 2020 Dec 31. |
| Background | 3. Singh M, Tiwari AB, Taank P, Singh S, Kaur A, Sood M, et al. Comparative study on effects of dexmedetomidine and dexamethasone on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic surgery. J Acute Dis. 2022 Apr 1;11(2):59-64. |
| 31031483 | Background | Reddy 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. |
| 31523579 | Background | Amreek F, Hussain SZM, Mnagi MH, Rizwan A. Retrospective Analysis of Complications Associated with Laparoscopic Cholecystectomy for Symptomatic Gallstones. Cureus. 2019 Jul 16;11(7):e5152. doi: 10.7759/cureus.5152. |
| Feb 15, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2026 | Feb 15, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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