Effect of Adding Azithromycin to Dexamethasone in Preventing Post-operative Nausea and Vomiting in Caesarean Section Under Spinal Anesthesia With Spinal Opiate.
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 主要终点
- Direct questionnaire of the patients about their nausea and/or vomiting
研究概览
简要总结
Postoperative nausea and vomiting is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery in inpatients. Postoperative nausea and vomiting is one of the most common causes of patient dissatisfaction after anesthesia, with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In addition, postoperative nausea and vomiting is regularly rated in preoperative surveys, as the anesthesia outcome the patient would most like to avoid. While suture dehiscence, aspiration of gastric contents, esophageal rupture, and other serious complications associated with postoperative nausea and vomiting are rare, nausea and vomiting is still an unpleasant and all-too-common postoperative morbidity that can delay patient discharge from the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.
详细描述
There are many well-established risk factors for Postoperative nausea and vomiting which are classified in two classes:
A) Patient related risk factors:
- Female gender is consistently the strongest risk factor for postoperative nausea and vomiting, female patient are three times more likely than men to suffer from postoperative nausea and vomiting.
- For adult patient, age is a statistically, though not clinically, relevant risk factor, with the incidence of postoperative nausea and vomiting decreasing as patients age. For pediatric patients, however, age increases the risk of post-operative vomiting , such that children older than 3 years have been shown to have an increased risk of post-operative vomiting compared with children younger than 3 years.
- Obesity is a strong risk factor for postoperative nausea and vomiting : patients with body mass index more than 30 have the double risk of postoperative nausea and vomiting.
- Non-smoking status roughly doubles the patient's risk of postoperative nausea and vomiting. The specific mechanism underlying smoking's protective effect is unknown, but one of the most commonly believed theories is that polycyclic aromatic hydrocarbons in cigarette smoke induce cytochrome P450 enzyme which increase the metabolism of emetogenic volatile anesthetics.
- History of gastrointestinal disease as gastritis, gastric ulcer or duodenal ulcer increases the risk for postoperative nausea and vomiting.
- History of motion sickness, Meniere's disease or previous postoperative nausea and vomiting indicates a general susceptibility to postoperative nausea and vomiting.
B) Anesthesia related risk factors:
- The use of volatile anesthetics is associated with a two-fold increase in the risk of postoperative nausea and vomiting , with risk increasing in a dose dependent manner.
- Intraoperative and postoperative opioid use increases the risk of postoperative nausea and vomiting in a dose dependent manner by the mechanism of reducing muscle tone and peristaltic activity, thereby delaying gastric emptying, inducing distention, and triggering the vomiting reflex.
- The duration of anesthesia can help predict the patient's risk of postoperative nausea and vomiting, since the duration of anesthesia describes the patient's exposure to emetogenic stimuli like volatile anesthetics and intraoperative opioids.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1- women classified according to American Society of anaesthesiologists grade I between the ages 18 to 38 years scheduled for elective Caesarean Section under spinal anesthesia who are normal healthy women, non smokers, no or minimal alcohol use.
- •2- women classified as American Society of Anaesthesiologists grade Il between the ages 18 to 38 years scheduled for elective Caesarean Section under spinal anesthesia who are women with mild systemic disease without functional limitations as current smokers, social alcohol drinker, pregnant, women with body mass index between 30 and 40, women with well-controlled diabetas, hypertension or mild lung diseases.
排除标准
- •Women who has obstetric complications.
- •Women with evidence of foetal compromise.
- •Patients who have gastro-intestinal diseases.
- •Patients who administrated anti-emetic medication in the previous 24 hours before operation.
研究组 & 干预措施
placebo group
The patients will receive oral placebo tablet, one hour before induction of anesthesia and 5 mg Intra-venous dexamethasone within 1-2 minutes after the umbilical cord is clamped.
干预措施: Intravenous dexamethasone (Drug)
Azithromycin group
The patients will receive 250 mg oral Azithromycin tablet, one hour before induction of anesthesia and 5 mg Intra-venous dexamethasone within 1-2 minutes after the umbilical cord is clamped.
干预措施: Oral Azithromycin tablet (Drug)
Azithromycin group
The patients will receive 250 mg oral Azithromycin tablet, one hour before induction of anesthesia and 5 mg Intra-venous dexamethasone within 1-2 minutes after the umbilical cord is clamped.
干预措施: Intravenous dexamethasone (Drug)
结局指标
主要结局
Direct questionnaire of the patients about their nausea and/or vomiting
时间窗: The first 24 hours after surgery
1. Did you experience nausea during the first 24 hours after your surgery? 1. yes 2. no \[if no, please skip to question 5\] 2. How long did the nausea last? ....... hours. 3. How would you describe the nausea at its worst? 1. mild 2. moderate 3. severe 4. intolerable 4. How many times you felt nauseated? ...... 5. Did you experience vomiting during the first 24 hours after your surgery? 1. yes 2. no \[ if no, please skip the next part of the questionnaire\] 6. How would you describe the vomiting at its worst? 1. mild 2. moderate 3. severe 4. intolerable 7. How many times you vomited during the first 24 hours after your surgery? ....... 8. Estimate the amount of the vomiting? 1. small amount 2. moderate amount 3. large amount
次要结局
未报告次要终点
研究者
KAGergis
principal investigator
Assiut University