Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery
试验速览
- 阶段
- 早期 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Enhanced recovery score
研究概览
简要总结
Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.
详细描述
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (T group and F group). Using computer generated randomization table; each group consists of 51 patients:Group (T) (n=51): Patients will receive preemptive intravenous infusion of tramadol plus paracetamol .
Group (F) (n=51): Patients will receive preemptive intravenous fentanyl.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for day case surgeries.
- •Patient acceptance to be included into the study.
- •Both sex.
- •Patients with ASA physical status I, II.
- •BMI 25 - 30 kg m-
- •Duration of surgery from 1-2 hours
排除标准
- •Uncooperative patients and patients with psychological problems.-
- •Patients with liver or renal impairment.
- •Patients with history of allergy to drug used in the study.
- •Patients with chronic pain.
- •Patient on pain therapy.
研究组 & 干预措施
tramadol plus paracetamol (T)
干预措施: tramadol plus paracetamol (Drug)
tramadol plus paracetamol (T)
干预措施: propofol and muscle relaxant (cisatracurium) (Drug)
fentanyl(F)
干预措施: Fentanyl (Drug)
fentanyl(F)
干预措施: Propofol (Drug)
结局指标
主要结局
Enhanced recovery score
时间窗: at the end of 24 hour after surgery.
A 40-item questionnaire that provides a score (QoR-40) that measure quality of recovery after surgery and anesthesia (enhanced recovery) according to five aspects will be recorded at the end of 24 hours after surgery: Emotional state(n=9) physical comfort(n=12) Psychological support (n=7) physical independence(n=5) pain(n=7) - Each one of the 40 questions gets a score from one to five at which one is the worst response and five is the best response. When the individual score of all questions are added together we get a total score that ranges from 40 to 200.
次要结局
- The duration of PACU stay(2 days postoperative)
- Duration of postoperative hospital stay(2 days postoperative)
- Postoperative pain severity(recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based)
- postoperative agitation score(immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU:)
研究者
Marwa Mohamed Medhat
assistant professor of anesthesia and surgical intensive care(Principal Investigator)
Zagazig University