Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy
2026年9月2日 更新者：Dr. Asifa Saeed、Faisalabad Medical University
Time-to-first-rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy: a Randomized, Triple-Blind, Superiority Trial
The goal of this superiority randomized controlled trial (RCT) is to learn if one dual-drug arm increases patient comfort (time to needing rescue medication for nausea/vomiting) more effectively than the other in adults with Moderate-to-High PONV risk (Apfel score 2-4) undergoing elective laparoscopic cholecystectomy (gallbladder surgery).
The main question this study aims to answer is:
• Does Ondansetron plus Metoclopramide prolong time to first rescue antiemetic more than Dexamethasone plus Metoclopramide?
Researchers will compare Group A (Ondansetron 4mg plus Metoclopramide 10mg IV) to Group B (Dexamethasone 8mg IV plus Metoclopramide 10mg IV) to see if Group A provides a longer time to first rescue medication.
Participants will:
- Receive their assigned, blinded drug group 5-10 minutes before general anesthesia induction.
- Receive rescue Metoclopramide 10mg IV if they experience any vomiting or severe nausea
- Be monitored for 24 hours post-surgery in the hospital
- Report nausea severity at 2, 6, 12 and 24 hours post-surgery
研究概览
研究类型
介入性
注册 (估计的)
264
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Asifa Saeed, MBBS; FCPS
- 电话号码：+923006694460
- 邮箱：drasifasaeed@gmail.com
研究联系人备份
- 姓名：Huda Ather, MBBS
- 电话号码：+923047922909
- 邮箱：atherhudaather@gmail.com
学习地点
-
-
Punjab Province
-
Faisalābad、Punjab Province、巴基斯坦、38000
- 招聘中
- Faisalabad Medical University
-
接触：
- Asifa Saeed, MBBS; FCPS
- 电话号码：+923006694460
- 邮箱：drasifasaeed@gmail.com
-
接触：
- Huda Ather, MBBS
- 电话号码：+923047922909
- 邮箱：atherhudaather@gmail.com
-
首席研究员：
- Asifa Saeed, MBBS; FCPS
-
副研究员：
- Huda Ather, MBBS
-
副研究员：
- M. Ibtisam Ahmad, MBBS
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy
- Apfel score 2-4 (moderate to high risk for PONV)
- Provides written informed consent prior to enrollment
Exclusion Criteria:
- Known allergy or hypersensitivity to ondansetron, dexamethasone, or metoclopramide
- Emergency surgery (e.g., acute cholecystitis, perforation, or gangrene)
- Pregnancy or breastfeeding
- ASA physical status III or IV
- Preexisting hepatic impairment
- Baseline corrected QT (QTc) interval > 420 ms on pre-operative ECG
- History of dystonic reaction to metoclopramide or other dopamine antagonists
- Preexisting renal impairment (e.g., serum creatinine > 1.5 mg/dL or on dialysis)
- Unable or unwilling to provide informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group A (Ondansetron and Metoclopramide)- Separate syringes
Participants receive
|
Ondansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
其他名称：
Metoclopramide 10 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia as part of dual-agent PONV prophylaxis.
Also used as rescue antiemetic (10 mg IV) if patient has vomiting or VRS >4 for nausea.
其他名称：
|
|
有源比较器：Group B (Dexamethasone and Metoclopramide)- Separate syringes
Participants receive
|
Metoclopramide 10 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia as part of dual-agent PONV prophylaxis.
Also used as rescue antiemetic (10 mg IV) if patient has vomiting or VRS >4 for nausea.
其他名称：
Dexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to First Rescue Antiemetic (in minutes)
大体时间：First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)
|
Time in minutes from patient arrival to Post-anaesthesia care unit, PACU (time zero) to administration of rescue metoclopramide 10 mg IV.
Rescue is given if patient experiences any episode of vomiting/retching or reports a nausea Verbal Rating Scale (VRS) score >4.
VRS scale is no nausea (0), mild (1-3), moderate (4-6), and severe (7-10).
|
First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Rescue Doses Required
大体时间：First 24 hours after surgery
|
Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours.
|
First 24 hours after surgery
|
|
Incidence of PONV
大体时间：24 hours post-surgery
|
Proportion of patients experiencing any nausea (VRS >1) or any vomiting/retching episode within the first 24 hours post-surgery. Verbal Rating Scale (VRS) is a well established measurement scale with a total of 11 points where 0 = no nausea and 10 = worst possible nausea. |
24 hours post-surgery
|
|
Severity of Postoperative Nausea and Vomiting (RINVR Score)
大体时间：Measured at 2, 6, 12, and 24 hours post-surgery
|
Measured using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
It evaluates 8 dimensions: frequency/duration/distress of nausea; frequency/amount/distress of vomiting; and frequency/distress of retching.
Total score range is 0-32, with 0 indicating no nausea, 1-8 mild, 9-16 moderate, 17-24 severe, and 25-32 great nausea.
The higher scores indicate worse PONV.
|
Measured at 2, 6, 12, and 24 hours post-surgery
|
|
Patient Satisfaction with Antiemetic Treatment
大体时间：At hospital discharge (approximately 24 hours post-surgery)
|
Patient-reported satisfaction measured on a 5-point Likert scale (Very Dissatisfied to Very Satisfied) at the end of hospital stay. Likert scale is a 5-point psychometric survey scale, with 1 indicating very disappointing and 5 indicating very satisfying. The higher the score, the better the treatment was. |
At hospital discharge (approximately 24 hours post-surgery)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse Events
大体时间：From drug administration up to 24 hours post-surgery
|
Proportion of patients experiencing any adverse reaction including allergic reaction, headache, perineal burning, dystonia, or QT prolongation on post-operative ECG.
|
From drug administration up to 24 hours post-surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Asifa Saeed, MBBS; FCPS、Faisalabad Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
- Mishriky BM, Habib AS. Metoclopramide for nausea and vomiting prophylaxis during and after Caesarean delivery: a systematic review and meta-analysis. Br J Anaesth. 2012 Mar;108(3):374-83. doi: 10.1093/bja/aer509. Epub 2012 Feb 3.
- Weibel S, Rucker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD012859. doi: 10.1002/14651858.CD012859.pub2.
- Alam, M. S., et al. (2025). Haloperidol Versus Dexmedetomidine As An Adjuvant to Ondansetron in Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy. Egyptian Journal of Surgery, 44(2), 456-463
- Abel UR, Jensen K, Karapanagiotou-Schenkel I, Kieser M. Some Issues of Sample Size Calculation for Time-to-Event Endpoints Using the Freedman and Schoenfeld Formulas. J Biopharm Stat. 2015;25(6):1285-311. doi: 10.1080/10543406.2014.1000546. Epub 2015 Jan 28.
- Naguib M, el Bakry AK, Khoshim MH, Channa AB, el Gammal M, el Gammal K, Elhattab YS, Attia M, Jaroudi R, Saddique A. Prophylactic antiemetic therapy with ondansetron, tropisetron, granisetron and metoclopramide in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind comparison with placebo. Can J Anaesth. 1996 Mar;43(3):226-31. doi: 10.1007/BF03011739.
- Chattopadhyay S, Biswas A, SK Samim Ferdows, Bhowmik DK, Dey S, Bi B. Comparison of Ondansetron, Dexamethasone and Ondansetron Plus Dexamethasone For The Prevention of Post-operative Nausea and Vomiting after Laparoscopic Cholecystectomy. Indian Journal of Clinical Anaesthesia. 2025;3(3):459-463. Accessed April 6, 2026.
- Korkusuz M, Et T. Effect of perioperative restrictive and liberal fluid regimens on postoperative nausea-vomiting and quality of recovery in laparoscopic cholecystectomy. World J Gastrointest Surg. 2025 Oct 27;17(10):110543. doi: 10.4240/wjgs.v17.i10.110543.
- Si XY, Wu LP, Li XD, Li B, Zhou YM. Dexamethasone combined with other antiemetics for prophylaxis after laparoscopic cholecystectomy. Asian J Surg. 2015 Jan;38(1):21-7. doi: 10.1016/j.asjsur.2014.04.005. Epub 2014 Jun 15.
- Ko-Iam W, Sandhu T, Paiboonworachat S, Pongchairerks P, Junrungsee S, Chotirosniramit A, Chotirosniramit N, Chandacham K, Jirapongcharoenlap T. Metoclopramide, versus its combination with dexamethasone in the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy: a double-blind randomized controlled trial. J Med Assoc Thai. 2015 Mar;98(3):265-72.
- Gan TJ, Jin Z, Ayad S, Belani KG, Habib AS, Meyer TA, Urman RD, Andrew BY, Bergese SD, Chung F, Diemunsch P, Kovac AL, Candiotti K, Englesakis M, Grant MC, Hedrick TL, Huang H, Kranke P, Lloyd SJ, Manahan MA, Minkowitz HS, Philip BK, Phillips BJ, Simpson KD, Stever J. Fifth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting: Executive Summary. Anesth Analg. 2025 Nov 14. doi: 10.1213/ANE.0000000000007816. Online ahead of print. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年4月1日
研究注册日期
首次提交
2026年6月4日
首先提交符合 QC 标准的
2026年6月4日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 术后并发症
- 病理过程
- 体征和症状，消化
- 呕吐
- 恶心
- 病理状况、体征和症状
- 体征和症状
- 术后恶心呕吐
- 硫化合物
- 有机化学品
- 杂环化合物，1形
- 杂环化合物
- 杂环化合物，2环
- 杂环化合物，融合环
- Azoles
- 碳氢化合物
- 碳氢化合物，循环
- 羧酸
- 羟基酸
- 碳氢化合物，芳香族
- 多环化合物
- 咪唑
- 酰胺
- 吲哚
- 怀孕
- 怀孕
- 类固醇
- 融合环化合物
- 类固醇，氟化
- 苯酚
- 苯衍生物
- 磺酸
- 硫酸
- 疗法
- 酸，碳环
- 苯磺酸盐
- 芳基磺酸盐
- 芳基磺酸
- para-aminobenzoates
- 氨基苯甲酸盐
- 苯甲酸盐
- 羟基苯甲酸盐
- 杂环化合物，三环
- 苯醚
- 苯甲酰基
- 氯苯甲酸盐
- 卡唑
- 羟基苯甲酸酯醚
- 地塞米松
- 昂丹司琼
- 甲氧氯普胺
- 羟苯磺酸钙
- 乙酸地塞米松
其他研究编号
- 48/ERC/FMU/2025-26/343
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared because the study is single-centre, small and unfunded.
Only aggregated, de-identified, summary data will besshared
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.