Clinical trial NCT06346522: Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Catheter-related Bladder Discomfort (CRBD)
Keywords: Catheter-related bladder discomfort (CRBD)
Gabapentin
Trospium chloride
Intensive Care Unit (ICU)
Postoperative care
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, comparative, clinical trial study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: * 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 eighty patients will be randomly assigned to one of the following two 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
* Incidence and severity of CRBD will be assessed by 4-point severity scale developed by Agarwal in 1,2,6,12,24 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 both groups to identify any significant differences between them

Eligibility criteria: Inclusion Criteria:

* Both males and females with age 20-60 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake
timeFrame: First 24 hours after the study drugs intake
Secondary outcomes:
measure: Total fentanyl requirements in micrograms (µg)
timeFrame: First 24 hours after the study drugs intake
measure: Numerical Pain Rating Scale (NPRS) (0-10)
timeFrame: First 24 hours after the study drugs intake
measure: Side effects of the study drugs
timeFrame: First 24 hours after the study drugs intake
measure: Ramsay sedation score
timeFrame: After one hour of the study drugs intake
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University-Faculty of Medicine
Study officials:
affiliation: Ain Shames University
name: Ahmed M Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19.
citation: Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.
citation: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.