跳至主要内容
临床试验/CTRI/2023/08/056491
CTRI/2023/08/056491尚未招募2 期

To assess the efficacy of addition of intravenous levosulpirideto dexamethasone as prophylaxis for PONV in patientsundergoing B/L TKR: a prospective, randomized, doubleblinded, controlled study".

Dr Sunny Rupal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Incidence of PONV

研究概览

简要总结

Total knee Arthroplasty remains one of the most commonly performed major orthopedic procedures. The number of procedures in most countries has increased rapidly over the past decade. The incidence of postoperative nausea and vomiting in patients undergoing Arthroplasty is high if not given any antiemetics. We will assess the efficacy of addition of intravenous levosulpiride to dexamethasone as prophylaxis for post operative nausea vomiting in patients undergoing Bilateral total knee replacement in a prospective, randomized, double blind manner. We will be having 100 patients with 50 in each group both male and female patients and excluding patients with history of anaphylaxis or allergy to the study drugs and patients refusing for consent etc.

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
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients scheduled for bilateral knee replacement surgery of ASA grade 1 and 2 , for degenerative joint disease.
  • Patients with APFEL score of at least 1 or more.

排除标准

  • ASA III, IV patients with severe illness
  • Patients with history of severe valular heart disease, vascular or conduction abnormalities
  • Known history of allergy to the study drugs
  • Any contraindication to spinal anesthesia or failure of spinal anesthesia necessitating general anesthesia
  • Patients with neurologic or cognitive disorders/ non cooperative patients/ patients with psychosis.
  • Patients with poor glycemic control HBA1c >
  • Severe hepatic or renal dysfunction
  • Intake of anti-emetics or steroids within last 24 hours of surgery
  • Patient’s refusal.

结局指标

主要结局

Incidence of PONV

时间窗: Till 24 hours

Incidence of nausea

时间窗: Till 24 hours

Incidence of vomiting

时间窗: Till 24 hours

2. Complete response of study drug (no nausea or vomiting or need of rescue drugs)

时间窗: Till 24 hours

次要结局

  • Time of onset(Time of severity & duration of PONV)

研究者

发起方
Dr Sunny Rupal
申办方类型
Other [self]

研究点 (1)

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