Clinical trial NCT04314050: Comparison of Tramadol and Dexmedetomidine in the Prevention of Urinary Catheter Discomfort in Urinary Surgery
Official title: Comparison of Different Strategies in Preventing Discomfort Due to Urine Catheter in Urinary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Complication
Keywords: dexmedetomidine
tramadol
catheter-related bladder discomfort
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 135
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aimed to compare the effects of tramadol and dexmedetomidine, which are commonly used in anesthesia, on preventing catheter-related bladder discomfort.

Detailed description: Urinary catheterization is an attempt frequently used in many surgeries, emergency services or intensive care units, especially urinary surgeries to facilitate urine output or evaluate urine output. However, as a result of urinary catheter application, most patients may develop some symptoms like pain, burning sensation and the urge to urinate constantly in the suprapubic region that the investigators call this catheter-related bladder discomfort (CRBD).

The incidence of CRBD can increase 47 to 90% in the postoperative period. The main reason of CRBD is involuntary contractions caused by muscarinic receptors, especially type 3 (M3) receptors. Therefore, antimuscarinic drugs are used to prevent and treat CRBD. Studies have shown that many drugs such as ketamine, tolterodine, oxybutynin, gabapentin, pregabalin, butylscopolamine, tramadol, dexmedetomidine are effective in preventing CRBD. Their common feature is antimuscarinic effects. However, no definitive conclusion could be reached for routine use, due to the low number of samples in the studies, surgical differences or some anticholinergic and sedative side effects. Additionally, oxybutynin, tolterodine, gabapentin, and pregabalin are only preoperatively administered orally. So more research is needed to find the ideal agent to prevent CRBD.

Tramadol is frequently used for moderate pain in surgeries. It is a centrally acting synthetic opioid analgesic that has an inhibitory effect on M1 and M3 muscarinic receptors. Tramadol has proven to be effective in reducing the severity and frequency of ICBR in intraoperative use. However, like other opioids, it can have side effects such as nausea-vomiting and sedation.

Dexmedetomidine is a selective alpha-2 adrenoceptor agonist that has analgesic, sympatholytic and sedative properties. In recent studies, it has been reported that dexmedetomidine is associated with the pathophysiology of CRBD by inhibiting type-3 (M3) muscarinic receptor which has beneficial effects in preventing CRBD in intraoperative use. Dexmedetomidine decreases the frequency of CRBD by 30%.

The first purpose of the study is to compare the effects of dexmedetomidine and tramadol on CRBD. Secondarily, the investigators aimed to compare them for their side effects.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 70 years
* American Society of Anesthesiologists I or II
* Scheduled to undergo retrograde intrarenal surgery
* Scheduled to apply urinary catheter intraoperatively

Exclusion Criteria:

* History of bladder outlet obstruction (Bening prostatic hypertrophy)
* History of neurogenic bladder
* History of psychiatric illness
* Obese patient
* Patients whose urinary catheter cannot be inserted
* Patients who had previously urinary catheters

Primary outcomes:
measure: the severity of CRBD
timeFrame: 0. hour
measure: the severity of CRBD
timeFrame: 1. hour
measure: the severity of CRBD
timeFrame: 3. hour
measure: the severity of CRBD
timeFrame: 6. hour
Secondary outcomes:
measure: 11-point numerical rating scale (NRS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Training and Research Hospital
Study officials:
affiliation: Ankara Diskapi Research and Training Hospital
name: Fatma Özkan Sipahioglu, specialist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hur M, Park SK, Yoon HK, Yoo S, Lee HC, Kim WH, Kim JT, Ku JH, Bahk JH. Comparative effectiveness of interventions for managing postoperative catheter-related bladder discomfort: a systematic review and network meta-analysis. J Anesth. 2019 Apr;33(2):197-208. doi: 10.1007/s00540-018-2597-2. Epub 2019 Jan 2.
citation: Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.
citation: Kim HC, Lee YH, Jeon YT, Hwang JW, Lim YJ, Park JE, Park HP. The effect of intraoperative dexmedetomidine on postoperative catheter-related bladder discomfort in patients undergoing transurethral bladder tumour resection: A double-blind randomised study. Eur J Anaesthesiol. 2015 Sep;32(9):596-601. doi: 10.1097/EJA.0000000000000196.
citation: Akca B, Aydogan-Eren E, Canbay O, Karagoz AH, Uzumcugil F, Ankay-Yilbas A, Celebi N. Comparison of efficacy of prophylactic ketamine and dexmedetomidine on postoperative bladder catheter-related discomfort. Saudi Med J. 2016 Jan;37(1):55-9. doi: 10.15537/smj.2016.1.14122.
citation: Li S, Song L, Ma Y, Lin X. Tramadol for the treatment of catheter-related bladder discomfort: a randomized controlled trial. BMC Anesthesiol. 2018 Dec 20;18(1):194. doi: 10.1186/s12871-018-0659-5.