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

Not Applicable

Completed

• Conditions: Catheter Related Complication
• Interventions: Other: control; Drug: Dexmedetomidine; Drug: Tramadol

• Registration Number: NCT04314050
• Lead Sponsor: Ankara Diskapi Training and Research Hospital

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.

Study Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Primary Completion: 2020-06-10
• Study Completion: 2020-07-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	1 gr paracetamol will perform intraoperatively
dexmedetomidine	Dexmedetomidine	1 mcg/kg dexmedetomidine bolus will perform after anesthesia induction and followed by infusion of 0.5 mcg/kg/h until 30 minutes before surgery completed. In addition, 1 gr paracetamol will be given intraoperatively.
tramadol	Tramadol	1,5 mg /kg tramadol will perform intraoperatively in 100 ml saline within 15 minutes at 30 minutes before surgery completed. In addition, 1 gr paracetamol will be given intraoperatively.

Primary Outcome Measures

Name	Time	Method
the severity of CRBD	6. hour	none - mild- moderate- severe

Secondary Outcome Measures

Name	Time	Method
11-point numerical rating scale (NRS)	24 hours	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained

Trial Locations

Locations (1)

Diskapi Training and Research Hospital; 🇹🇷 Ankara, Turkey