Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- measure incidence of postoperative nausea and vomiting
研究概览
简要总结
Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
详细描述
Laparoscopic surgeries have many advantages e.g., decreasing postoperative pain, better cosmetic, rapid recovery, and better recovery but also, it has side effects e.g., pain, postoperative nausea and vomiting.
There are many risk factors that cause PONV either patient related factors or anesthesia related factors (opioids, inhalational anesthetics, Nitrous oxide and duration of anesthesia) and surgery related factors (intraabdominal, laparoscopic, postoperative pain).
Intraperitoneal instillation of drugs can be used for instillation of LA, opoids, ketamine and antiemetics to provide analgesia and manage side effects of laparoscopic surgery. The mechanism of action of ondansetron is inhibition of presynaptic 5-HT3 receptors that located in the peripheral nervous. Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessor (anesthesiologist not sharing in the study) will assess outcome parameters
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from the patient.
- •Age: 21-60 years old.
- •female patients
- •Physical status: ASA 1& II.
- •BMI = ≤ 35 kg/m2).
- •Type of operation: elective laparoscopic gynecological surgeries.
排除标准
- •Altered mental state.
- •Patients with known history of allergy to the study drugs.
- •hepatic, renal impairment or disease , cardiovascular, and respiratory diseases.
- •Patients with chronic pain received NSAID or opioid during previous two weeks.
- •Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the surgery.
研究组 & 干预措施
Intraperitoneal instillation of ondansetron and bupivacaine (group A)
Patients will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % and (4 mg) 2 ml ondansetron through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.
干预措施: Intraperitoneal instillation of ondansetron and bupivacaine (Drug)
Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)
Patient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.
干预措施: Intravenous ondansetron and intraperitoneal instillation of bupivacaine (Drug)
Intraperitoneal instillation of bupivacaine (group C)
patient will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.
干预措施: Intraperitoneal instillation of bupivacaine (Drug)
结局指标
主要结局
measure incidence of postoperative nausea and vomiting
时间窗: 24 hours postoperative
The number of patient suffering from postoperative nausea and vomiting in each group
measure severity of postoperative nausea and vomiting
时间窗: 24 hours postoperative
Simplified Postoperative Nausea and Vomiting Impact Scale (S-PNVIS) 1. \*Frequency of Nausea:\* * 0: None * 1: Occasionally (1-2 times a day) * 2: Frequently (3-4 times a day) * 3: Constantly (more than 4 times a day) 2. \*Frequency of Vomiting:\* * 0: None * 1: Once a day * 2: 2-3 times a day * 3: More than 3 times a day 3. \*Impact on Daily Activities:\* * 0: No impact * 1: Mild impact (able to perform most activities) * 2: Moderate impact (some activities limited) * 3: Severe impact (most activities limited) #Scoring * \*Total Score:\* Sum of scores from all 3 items. * \*Interpretation:\* Higher total scores indicate a greater impact of nausea and vomiting on the patient recovery
次要结局
- measure total numbers of rescue antiemetic(all over 24 hours postoperative.)
- Duration of hospital stay(24 hours to 72 hours)
- postoperative pain by Numerical Rating Scale(0 hour (basal) in PACU, 2, 4, 8, 12, 24 hours postoperative)
- total dose of rescue analgesia postoperative(24 hours postoperative)
- Patient satisfaction(24 hours postoperative)
研究者
Dina Abdelhameed Elsadek Salem
principle investigator
Zagazig University