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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| -Group G (40 patients): Gabapentin | Active Comparator | 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 |
|
| -Group T (40 patients): Trospium chloride slow release | Active Comparator | 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 |
|
| Group C (40 patients): Non-pharmacological standard of care control group | No Intervention | Non-pharmacological standard of care control group who administered nothing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin (Gaptin ®) 400mg oral capsule once | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 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:
| First 24 hours after the study drugs intake |
| Measure | Description | Time Frame |
|---|---|---|
| Total fentanyl requirements in micrograms (µg) | Total fentanyl requirements in the 1st 24h after study drugs intake in micrograms (µg/day) | First 24 hours after the study drugs intake |
| Numerical Pain Rating Scale (NPRS) (0-10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Mohamed, MD | Ain Shames University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University-Faculty of Medicine | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34242915 | Background | 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. | |
| 16415311 | Result |
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The datasets used and analyzed during the current study are available from the corresponding author on reasonable request, with hiding of identities of participants or any personal information.
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A prospective, randomized, comparative, clinical trial study
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|
| Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule | Drug | 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 |
|
|
NPRS for measurement of surgical pain intensity. It consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').NPRS will be assessed at 1,2,6,12,24 hours after the study drugs intake.
| First 24 hours after the study drugs intake |
| Side effects of the study drugs | They includes:
| First 24 hours after the study drugs intake |
| Ramsay sedation score | Ramsay sedation score [3].It will be assessed after one hour of the study drugs intake Score Sedation level
| After one hour of the study drugs intake |
| 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. |
| 4835444 | Result | 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. |
| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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