Efficacy of Gabapentin Versus Trospium Chloride for Prevention of Catheter-related Bladder Discomfort (CRBD) Inside the Intensive Care Unit (ICU): a Prospective, Randomized,Comparative Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake
研究概览
简要总结
Catheter-related bladder discomfort (CRBD) is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period. CRBD shows similar symptoms to overactive bladder (OAB); so, drugs used for the management of OAB could influence symptoms of CRBD. Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases. We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder.
详细描述
- Study will be conducted in the intensive care units (ICU) of Ain Shams University Hospitals, Cairo, Egypt
- After satisfactory pain control and full recovery in the postanesthesia care unit (PACU), the patient will be transferred to the ICU as a case of postoperative care after elective spinal diskectomy surgeries (cervical, dorsal or lumber) with removal of the damaged portion of the herniated or degenerated disks. Admission to ICU will be for medical, surgical or anesthesia related causes.
- Standard monitoring devices via GE monitor will be connected to the patient as electrocardiogram (ECG) for heart rate (beats/min), pulse oximetry for (SPO2 as a percentage) and non-invasive blood pressure (NIBP) (mmHg).Temperature of the patient in Celsius (◦C), random blood sugar (mg/dl) and urine output (ml/hour) will be monitored also. Follow-up by standard postoperative laboratory tests will be done too.
- After the patient will regain feeding according to the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines [1],the consented and enrolled 120 patients will be randomly assigned to one of the following groups and oral drug will be taken with sips of water:
- Group G (40 patients): Gabapentin (GaptinR) 400mg oral capsule
- Group T (40 patients): Trospium chloride slow release (TrospikanR SR) 60mg oral capsule
- Group C (40 patients): Non-pharmacological standard of care control group who administered nothing
- Incidence and severity of CRBD will be assessed by 4-point severity scale developed by Agarwal in1,2,6,12,24 hours after the study drugs intake . Assessment of pain severity and control will be done by using Numerical Pain Rating Scale (NPRS) and measuring total fentanyl requirements in the 1st 24h in micrograms (µg/day). Side effects of the study drugs will be recorded and managed accordingly with the use of Ramsay sedation score to assess sedation level one hour after the study drugs intake .
- Patients will continue their monitored care in the ICU till the control of the causes of their ICU admission or their end.
- Demographic data, causes for postoperative care in the ICU (Medical, surgical or anesthesia related) and spine surgery site and number for each (cervical, dorsal, lumber) will be collected and recorded.The collected study data results will be revised, electronically recorded in datasheet, coded, tabulated, analyzed, and processed using the proper computerized statistical package program. Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between groups to identify any significant differences between them
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)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both males and females with age 20-65 years
- •American Society of Anesthesiologists (ASA) physical status class I, II or III.
- •Patients will undergoing elective spinal surgery and will require catheterization of the urinary bladder.
排除标准
- •known allergy to the study drugs or patient refusal.
- •Urinary bladder pathology as overactive bladder (frequency more than 3 times in the night or more than 8 times in 24 h), bladder outflow obstruction, urinary tract infection or malignancy
- •Preoperative neurological bladder and/or bowel involvement secondary to spinal cord compression.
- •Chronic opioids use for chronic pain, drugs or alcohol abuse
- •Moderate to severe hepatic disease, renal impairment with creatinine clearance (CrCl) less than 30 ml/minute
- •Narrow angle glaucoma
- •Psychiatric diseases
- •Gastrointestinal obstructive conditions as severe chronic constipation or ileus
研究组 & 干预措施
-Group G (40 patients): Gabapentin
After the patient will regain feeding, the patients will take with sips of water Gabapentin (Gaptin ®) 400mg oral capsule once in the first 24 hour after icu admission
干预措施: Gabapentin (Gaptin ®) 400mg oral capsule once (Drug)
-Group T (40 patients): Trospium chloride slow release
After the patient will regain feeding, the patients will take with sips of water Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule once in the first 24 hour after icu admission
干预措施: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule (Drug)
结局指标
主要结局
The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake
时间窗: First 24 hours after the study drugs intake
Severity of CRBD will be assessed and recorded by a CRBD 4-point severity scale developed by Agarwal et al as following: 1. No discomfort 2. Mild: urinary urgency or suprapubic discomfort reported by the patient on questioning only 3. Moderate: urinary urgency or suprapubic discomfort reported by the patient themselves without being questioned and not accompanied by behavioral changes 4. Severe: urinary urgency or suprapubic discomfort reported by the patient themselves and accompanied by behavioral changes such as attempts to remove the catheter, verbal responses, and restless movements of extremities) \[2\]
次要结局
- Total fentanyl requirements in micrograms (µg)(First 24 hours after the study drugs intake)
- Numerical Pain Rating Scale (NPRS) (0-10)(First 24 hours after the study drugs intake)
- Side effects of the study drugs(First 24 hours after the study drugs intake)
- Ramsay sedation score(After one hour of the study drugs intake)