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Completed

NCT Number: NCT04314050

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

tramadol and paracetamol will perform

Other names: Contramal

Dexmedetomidine

Drug

dexmedetomidine and paracetamol will perform

Other names: precedex

Control

Other

paracetamol will perform

Primary outcomes

  1. the severity of CRBD

    Time frame: 0. hour

    none - mild- moderate- severe

  2. the severity of CRBD

    Time frame: 1. hour

    none - mild- moderate- severe

  3. the severity of CRBD

    Time frame: 3. hour

    none - mild- moderate- severe

  4. the severity of CRBD

    Time frame: 6. hour

    none - mild- moderate- severe

Secondary outcomes

  1. 11-point numerical rating scale (NRS)

    Time frame: 24 hours

    11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained

Sponsors and collaborators

Lead sponsor

Ankara Diskapi Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2020
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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