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

Sponsor
Ankara Diskapi Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04314050
Collaborator
(none)
135
1
3
4
33.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Comparison of Different Strategies in Preventing Discomfort Due to Urine Catheter in Urinary Surgery
Actual Study Start Date :
Mar 10, 2020
Actual Primary Completion Date :
Jun 10, 2020
Actual Study Completion Date :
Jul 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Drug: Tramadol
tramadol and paracetamol will perform
Other Names:
  • Contramal
  • Active Comparator: 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.

    Drug: Dexmedetomidine
    dexmedetomidine and paracetamol will perform
    Other Names:
  • precedex
  • Placebo Comparator: control

    1 gr paracetamol will perform intraoperatively

    Other: control
    paracetamol will perform

    Outcome Measures

    Primary Outcome Measures

    1. the severity of CRBD [0. hour]

      none - mild- moderate- severe

    2. the severity of CRBD [1. hour]

      none - mild- moderate- severe

    3. the severity of CRBD [3. hour]

      none - mild- moderate- severe

    4. the severity of CRBD [6. hour]

      none - mild- moderate- severe

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diskapi Training and Research Hospital Ankara Turkey 06110

    Sponsors and Collaborators

    • Ankara Diskapi Training and Research Hospital

    Investigators

    • Principal Investigator: Fatma Özkan Sipahioglu, specialist, Ankara Diskapi Research and Training Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fatma Özkan Sipahioğlu, University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital, Department of Anesthesiology and Reanimation, Ankara Diskapi Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04314050
    Other Study ID Numbers:
    • Urinery Catheter Discomfort
    First Posted:
    Mar 18, 2020
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fatma Özkan Sipahioğlu, University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital, Department of Anesthesiology and Reanimation, Ankara Diskapi Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2021