跳至主要内容
临床试验/CTRI/2023/01/049005
CTRI/2023/01/049005尚未招募不适用

Comparison of Aprepitant, Dexamethasone and Ondansetron with Dexamethasone and Ondansetron for prevention of post operative nausea vomiting in high risk patients undergoing laparoscopic surgeries. A Randomised control trial.

AIIMS1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS
入组人数
200
试验地点
1
主要终点
TO COMPARE THE INCIDENCE OF POSTOPERATIVE NAUSEA AND VOMITING.

研究概览

简要总结

POST-OPERATIVE NAUSEA VOMITING OCCUR IN UPTO 30% OF ALL SURGICAL PATIENTS 70 - 80% OF HIGH RISK PATIENTS FOLLOWING SURGERY WITH NO PROPHYLACTIC ANTIEMETIC THERAPY. PONV CAN RESULT IN NUMEROUS ADVERSE EVENTS INCLUDING FLUID IMBALANCES, WOUND DEHISCENCE, ESOPHAGEAL TEARS AND RAISED INTRACRANIAL PRESSURE. IT INCREASES PATIENTS DISCOMFORT AS WELL AS DELAYS RECOVERY AND DISCHARGE RESULTING IN INCREASED HEALTH CARE COSTS. FEMALE SEX, YOUNGER AGE, NON SMOKING STATUS, POST-OPERATIVE OPOID ANALGESIA AND HISTORY OF MOTION SICKNESS ARE RISK FACTORS FOR PONV. THIS STUDY AIMS AT COMPARING THE INCIDENCES OF PONV AFTER TRIPLE DRUG PROPHYLAXIS (GROUP A) WITH APREPITANT 80MG, DEXAMETHASONE 8MG AND ONDANSETRON 4MG AS COMPARED TO THE ROUTINELY USED PROPHYLAXIS (GROUP C) WITH 8MG DEXAMETHASONE AND 4MG ONDANSETRON. FEMALES >18YRS, NON SMOKERS UNDERGOING LAPAROSCOPIC SURGERY LASTING 2-4 HOURS, RECEIVING INTRAOPERATIVE AND POSTOPERATIVE OPOID ANALGESIA WILL BE GIVEN APREPITANT 80MG IN GROUP A  ( 82 PARTICIPANTS) AND  PLACEBO IN GROUP C (82 PARTICIPANTS) 2HRS BEFORE THE SURGERY. PATIENTS WILL BE FOLLOWED UP AT TWO POINTS- 2HRS AND 24HRS AFTER SURGERY FOR THE INCIDENCE OF NAUSEA AND VOMITING (PRIMARY OUTCOME). THE SECONDARY OUTCOME WILL BE THE TIME TO FIRST RESCUE ANTIEMETIC AND AMOUNT CONSUMED IN FIRST 24 HOURS. TO QUANTIFY SYMPTOMS A PONV SCALE WILL BE USED. A PONV IMPACT SCALE SCORE OF MORE THAN OR EQUAL TO 5 WILL BE CONSIDERED CLINICALLY IMPORTANT PONV.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • •FEMALE >18 YRS,NON SMOKERS UNDERGOING LAPAROSCOPIC SURGERY LASTING 2-4 HOURS, RECEIVING INTRAOPERATIVE AND POSTOPERATIVE OPIOID ANALGESIA.

排除标准

  • •CONSUMPTION OF AN AGENT WITH ANTI EMETIC PROPERTIES WITHIN 24 HRS PRIOR TO COMMENCEMENT OF THE STUDY.
  • •KNOWN HYPERSENSITIVITY TO APREPITANT, ONDANSETRON OR DEXAMETHASONE.
  • •PATIENTS REQUIRING POSTOPERATIVE MECHANICAL VENTILATION.
  • •SURGERY LASTING >4 HRS
  • •PATIENTS NOT GIVING CONSENT.

结局指标

主要结局

TO COMPARE THE INCIDENCE OF POSTOPERATIVE NAUSEA AND VOMITING.

时间窗: 2 HOURS AND 24 HOURS FOLLOWING SURGERY.

次要结局

  • TIME TO FIRST RESCUE ANTIEMETIC AND THE AMOUNT OF ANTIEMETIC CONSUMED.(FIRST 24 HOURS.)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital

研究点 (1)

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