The Effectiveness of Intravenous Dexamethasone Prophylaxis in Preventing Post-operative Urinary Retention in Spinal Anesthesia at Al-Makassed Hospital
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,084
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Urinary Retention (POUR)
研究概览
简要总结
What is this study about? This study is testing whether a common medication called dexamethasone, given through a vein (IV) before surgery, can help prevent a problem called postoperative urinary retention (POUR). POUR means having trouble urinating after surgery, which can cause discomfort and sometimes requires using a catheter.
Who can join the study? The study includes adult People who are having surgery with spinal anesthesia at Al-Makassed Hospital. People who have certain medical conditions, use steroids regularly, or need a catheter during surgery cannot join.
What will happen in the study?
Participants will be randomly assigned to one of two groups:
- One group will get 8 mg of IV dexamethasone before surgery.
- The other group will get a saltwater (placebo) injection. Neither the participants nor the doctors will know which treatment they receive.
After surgery, the researchers will check how soon each participant can urinate and whether they need a catheter.
Why is this study important? POUR can slow recovery and cause complications. Dexamethasone is already used for other reasons like nausea and swelling. This study will help find out if it also lowers the risk of POUR in people getting spinal anesthesia.
详细描述
Postoperative urinary retention (POUR) is a common complication following spinal anesthesia, affecting patient comfort, recovery, and sometimes requiring catheterization. While dexamethasone is routinely used to prevent nausea and inflammation in surgical patients, its potential role in preventing POUR has not been fully explored, especially in the context of spinal anesthesia.
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial conducted at Al-Makassed Hospital. It aims to evaluate whether a single preoperative intravenous dose of 8 mg dexamethasone reduces the incidence of POUR in adult patients undergoing elective surgery under spinal anesthesia.
Eligible participants are randomized into two equal groups using block randomization. One group receives 8 mg of IV dexamethasone, and the other receives a placebo (0.9% saline). Both patients and assessors are blinded to group assignment. Data will be collected on age, BMI, comorbidities (including history of BPH or prior POUR), current anticholinergic drug use, anesthetic agent and dose, which level of spinal anesthesia (e.g. L3-L4), type of surgery, IV fluid volume, and duration of operation.
The primary outcome is the incidence of POUR, defined as failure to void within 6 hours after surgery and requiring catheterization. Secondary outcomes include time to first void and the overall need for urinary catheterization. Safety data will also be recorded, and any adverse events related to dexamethasone will be reported.
The study has been approved by the Al-Quds University Research Ethics Committee. All participants will provide informed consent prior to enrollment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blinded study. Both participants and outcome assessors are unaware of the group assignments. A non-participating physician performed the randomization using a computer-generated block randomization list. Study drugs (dexamethasone or placebo) are prepared in identical syringes labeled with participant codes only, ensuring that care providers and investigators remain blinded during the intervention and follow-up period.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients at Al-Makassed Hospital undergoing spinal anesthesia for surgery
排除标准
- •Chronic steroid use
- •Individuals who should not be administered dexamethasone
- •Have a history of urological issues or procedures
- •Have neurological disorders
- •Using an intraoperative Foley's catheter
- •Operations for possible nerve damage
研究组 & 干预措施
Arm 2: Placebo Group (Participants receiving intravenous 0.9% saline as placebo)
Participants in this arm will receive an intravenous injection of 0.9% normal saline (placebo) before undergoing surgery under spinal anesthesia. This group is used to compare the effect of dexamethasone on the incidence of postoperative urinary retention (POUR).
干预措施: Normal Saline (0.9% NaCl) (Drug)
Arm 1: Dexamethasone group
Participants in this arm will receive a single 8 mg dose of intravenous dexamethasone before undergoing surgery under spinal anesthesia. The intervention is administered preoperatively to evaluate its effectiveness in reducing the risk of postoperative urinary retention (POUR).
干预措施: Dexamethasone (IV) (Drug)
结局指标
主要结局
Incidence of Postoperative Urinary Retention (POUR)
时间窗: Measured within 6 hours postoperatively.
The percentage of participants who fail to void within 6 hours after surgery and require urinary catheterization.
次要结局
- Time to First Urination(Recorded within the first 24 hours after surgery.)
- Need for Urinary Catheterization(During hospital stay post-surgery (up to 24 hours))
- Adverse Events Related to Dexamethasone(From drug administration to 24 hours postoperative.)
研究者
Abeer Hasan
Abeer Jafar Dar Hasan , General Surgery Senior Resident, MBBS
Al-Quds University