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临床试验/CTRI/2018/01/011345
CTRI/2018/01/011345已完成Unknown

Comparison of ramosetron and ondansetronf for prevention of early and delayed Post operative nausea and vomiting following craniotomy

Obaid Ahmad Siddiqui1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年4月1日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
- POST OPERATIVE NAUSEA AND VOMITING.

研究概览

简要总结

Weconducted a prospective,randomized, double-blinded study to compare the efficacy of Ondansetron withRamosetron in preventing early (0-24 hours) and delayed (24-48 hours)post-operative nausea and vomiting (PONV) in 130 patients undergoing craniotomyunder general anaesthesia.

The study was conducted after obtaininginstitutional ethical committee clearance and written informed consent from allpatients. Thorough pre-anaesthetic evaluation was done, investigations werenoted.

Patients were randomized into two groups,ondansetron group (control group) and ramosetron group (study group) of 65patients each using a computer generated randomization table.

Patients in both the groups were administeredgeneral anaesthesia using the same anaesthetic protocol. Patients in controlgroup were given Injection ondansetron 4mg IV while patients in study groupreceived injection ramosetron 0.3 mg IV 30 minutes before closure of skin.

In the post-operative period, patients were monitored for nausea,vomiting, pain and vital signs. Patients were closely monitored for 48 h andany complaint of nausea, retching, and vomiting or adverse drug effect wasrecorded by an independent observer (usually a Resident Doctor) who was blindedto the study. Inj. Metoclopramide (0.15 mg/kg I.V.) was administered as anadditional rescue antiemetic in patients with two or more than two episodes ofvomiting and/or significant nausea at any time within 48 hours of operation.Exact timing of the administration of the rescue antiemetic was recorded.

Patients in both the groups werefound to be comparable in terms of age, height, weight, ASA status, nature ofsurgery (tumour/vascular), pre-operative heart rate and mean arterial pressure(MAP) with no statistical significance.

Also, all the patients underwent craniotomiesand the mean duration of anaesthesia and the mean duration of surgery were alsocomparable with no statistical significance.

The incidence and severity ofdelayed vomiting and retching were significantly lesser in Ramosetron group ascompared to Ondansetron group.

Sofrom our study we derive that Ramosetron is better than ondansetron atpreventing delayed PONV (24-48 Hours) after craniotomy under generalanaesthesia. However, both the drugs are comparable in preventing early PONV(0-24 Hours). The incidence of side effects is similar in Ondansetron andRamosetron.

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

入选标准

  • 1.ASA I & II patients.
  • 2.Mallampatti grades I & II.

排除标准

  • 1.Patients with a history of motion sickness, Gastroesophageal Reflux Disease (GERD).
  • 2.Patients with major Cardiovascular Disease, Respiratory Disease and uncontrolled diabetes mellitus.
  • 3.Patients with anticipated difficult intubation.
  • 4.History of alcohol, drug abuse or smokers.
  • 5.Post operative Glasgow Coma Score (GCS) less than 8.

结局指标

主要结局

- POST OPERATIVE NAUSEA AND VOMITING.

时间窗: -NAUSEA VOMITING RETCHING

次要结局

  • SIDE EFFECTS OF DRUGS USED(Dizziness)

研究者

发起方
Obaid Ahmad Siddiqui
申办方类型
Government medical college

研究点 (1)

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