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临床试验/NCT04697277
NCT04697277Unknown4 期

The Effect of Antibiotic Prophylaxis Timing on Intraoperative Nausea and Vomiting in Patients Undergoing Cesarean Section Under Regional Anesthesia.

Baskent University Ankara Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年8月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
120
试验地点
1
主要终点
Intraoperative nausea-retching-vomiting episodes

研究概览

简要总结

The incidence of intraoperative nausea and vomiting in patients who undergo caesarean section (C/S) under regional anesthesia is approximately 30-80%. Hypotension, pain, visceral manipulation, fundal pressure, removal of the uterus during repair, intra-abdominal irrigation, central neural opioids, intravenous oxytocin and antibiotics are possible risk factors. Oxytocin and prophylactic antibiotics are administered simultaneously during C/S operation, especially after the umbilical cord is clamped. Simultaneous administration of drugs such as oxytocin and prophylactic antibiotics may induce nausea and vomiting after umbilical cord clamping in the patient. In this study, it was aimed to investigate the effect of prophylactic antibiotic administration 30 minutes before the incision and after cord clamping on intraoperative nausea and vomiting in patients undergoing elective C/S under regional anesthesia.

This study was planned to be carried out in Başkent University Zübeyde Hanım Research Center Operating Room with 120 pregnant women (≥ 37 gestational weeks) undergoing elective C/S under regional anesthesia in a prospective, randomized, double-blind manner.

Group 1 (Prophylactic antibiotic 30 minutes before skin incision): Antibiotic diluted in 10 ml syringe 30 minutes before skin incision and after cord clamping, 0.9% NaCl in 10 ml syringe will be administered intravenously within 15 seconds.

Group 2 (prophylactic antibiotic after cord clamping): 30 minutes before the skin incision, 0.9% NaCl in a 10 ml injector and after the cord is clamped, the antibiotic diluted in a 10 ml syringe will be administered intravenously within 15 seconds.

Intraoperative nausea-retching-vomiting episodes (0 = No symptoms, 1: Nausea (uncomfortable feeling with vomiting), 2: Gag (vomiting effort in which gastric contents cannot be expelled), 3: Vomiting (Gastric contents are forced by mouth. ejection)] will be recorded. Nausea scores will be evaluated on the verbal analog scale (VAS) with 11 points (0 = no nausea, 10 = the most severe nausea). Before anesthesia, all patients will be informed about the verbal analog scale (VAS) for nausea. VAS 1-3 = Mild Nausea, VAS 4-6 = Moderate nausea, VAS 7-10 = Severe nausea. Evaluations will be made at certain time intervals.

Before CSEA application Time interval between CSEA application and fetus discharge Time interval between fetus exit and expulsion of the uterus Time interval between expulsion of the uterus and insertion into the abdomen Time interval between insertion of the uterus in the abdomen and closing the fascia Time interval between fascia closure and skin closure Time interval between skin closure and patient transport to the recovery unit Nausea-retching-vomiting episodes, current systolic/diastolic blood pressure values, nausea-vomiting scores, antiemetic and / or ephedrine requirement, amount of intravenous fluid infused will be recorded.

Intraoperative prophylactic antibiotic use is considered as one of the possible causes of intraoperative nausea and vomiting in patients who underwent cesarean section under regional anesthesia. We believe that the results of our study can make contribution on both intraoperative nausea-vomiting etiology in cases undergoing cesarean section under regional anesthesia and the steps that can be taken to prevent it.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

A computer-generated random numbers table and sealed envelopes will be used to ensure randomization. The gynecologist performing the surgery, the anesthesiologist and the patients will not know the Group allocation. The medications will be prepared by the anesthesia technician responsible for the study. Prophylactic antibiotic and placebo will be prepared in 10 ml in the syringe and labeled as study drug.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women (≥ 37 gestational weeks) undergoing elective C/S under regional anesthesia

排除标准

  • Emergency C/S cases
  • Patients who had nausea before C/S
  • Patients who used antiemetics within 24 hours before C/S
  • Patients who have a history of smoking, postoperative nausea-vomiting, motion sickness, and hyperemesis before C/S
  • Patients with history of diabetes, morbid obesity (Body Mass Index> 40) and gastrointestinal disease
  • Psychiatric disorders
  • Patients who are allergic to the drugs to be used in the study
  • Patients for whom regional anesthesia is contraindicated

研究组 & 干预措施

Group 1

Active Comparator

Group 1 (Prophylactic antibiotic 30 minutes before skin incision): Antibiotic diluted in 10 ml syringe 30 minutes before skin incision and after cord clamping, 0.9% NaCl in 10 ml syringe will be administered intravenously within 15 seconds.

干预措施: Antibiotic prophylaxis timing (before skin incision and after cord clamping) for caesarean section (Drug)

Group 2

Active Comparator

Group 2 (prophylactic antibiotic after cord clamping): 30 minutes before the skin incision, 0.9% NaCl in a 10 ml injector and after the cord is clamped, the antibiotic diluted in a 10 ml syringe will be administered intravenously within 15 seconds.

干预措施: Antibiotic prophylaxis timing (before skin incision and after cord clamping) for caesarean section (Drug)

结局指标

主要结局

Intraoperative nausea-retching-vomiting episodes

时间窗: Intraoperative

0 = No symptoms, 1: Nausea (uncomfortable feeling with vomiting), 2: Gag (vomiting effort in which gastric contents cannot be expelled), 3: Vomiting (Gastric contents are forced by mouth. ejection)

次要结局

  • Nausea score(Intraoperative)

研究者

发起方
Baskent University Ankara Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahattin Tuncali

Associate professor, MD

Baskent University Ankara Hospital

研究点 (1)

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