Comparison of Tramadol and Dexmedetomidine in the Prevention of Urinary Catheter Discomfort in Urinary Surgery

Catheter Related Complication Clinical Trial

Official title:

Comparison of Different Strategies in Preventing Discomfort Due to Urine Catheter in Urinary Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314050
• Other study ID #: Urinery Catheter Discomfort
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: July 10, 2020

Study information

• Verified date: November 2021
• Source: Ankara Diskapi Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 10, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Complication

Intervention

Drug:
• Tramadol
tramadol and paracetamol will perform
• Dexmedetomidine
dexmedetomidine and paracetamol will perform

Other:
• control
paracetamol will perform

Locations

Country	Name	City	State
Turkey	Diskapi Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Akça B, Aydogan-Eren E, Canbay Ö, Karagöz AH, Üzümcügil F, Ankay-Yilbas A, Çelebi 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the severity of CRBD	none - mild- moderate- severe	0. hour
Primary	the severity of CRBD	none - mild- moderate- severe	1. hour
Primary	the severity of CRBD	none - mild- moderate- severe	3. hour
Primary	the severity of CRBD	none - mild- moderate- severe	6. hour
Secondary	11-point numerical rating scale (NRS)	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained	24 hours