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