The Impact of Timing and Dosing of Dextrose Solution on Postoperative Nausea and Vomiting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative nausea and vomiting within 24 hour
研究概览
简要总结
The aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting.
详细描述
All patients signed informed consent after excluding patients not candidate for the study.patients were divided to three groups, taking either 0.9% saline as control group(group C), dextrose 5%(group D5) or dextrose 10%(group D10).
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female non-smokers adults (age 18-65 years)
- •ASA I-II who were listed for elective surgery under general anesthesia (surgery which is risk for PONV).
排除标准
- •Severe hypertension
- •Coagulopathy
- •Significant hepatic or renal disease
- •Diabetes mellitus or abnormal blood glucose on the morning of surgery
- •Withdrawal of consent
- •Severe intraoperative hypotension requiring large volume intravascular fluid treatment
- •Protocol violations including nitrous oxide administration.
研究组 & 干预措施
Dextrose 5%
100 mL/ hour of dextrose 5% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon to assess the timing and dosing of dextrose solution effect on PONV.
干预措施: Dextrose 5% in water (Other)
Dextrose 10%
100 mL/ hour of dextrose 10% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon
干预措施: Dextrose 10% (Other)
Saline placebo
100 mL/ hour of normal saline were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon
干预措施: Saline placebo (Other)
结局指标
主要结局
Postoperative nausea and vomiting within 24 hour
时间窗: 24hour after surgery
Number of participants who experienced PONV grade ≥2 as assessed by PONV score . The PACU nurses assessed and documented PONV using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; thus 5 scores were recorded during PACU stay. A 24-hour PONV assessment that elicited any nausea and emesis episode since PACU discharge was obtained by a blinded investigator by telephone or in person at the patient's bedside (delayed PONV).
次要结局
- Number of doses of antiemetics required to control PONV.(24hour postoperative)
- Number of classes of antiemetics(24 hour postoperative)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University