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

November 8, 2021 updated by: Fatma Özkan Sipahioğlu, Ankara Diskapi Training and Research Hospital

Comparison of Different Strategies in Preventing Discomfort Due to Urine Catheter 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Diskapi Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the severity of CRBD
Time Frame: 0. hour
none - mild- moderate- severe
0. hour
the severity of CRBD
Time Frame: 1. hour
none - mild- moderate- severe
1. hour
the severity of CRBD
Time Frame: 3. hour
none - mild- moderate- severe
3. hour
the severity of CRBD
Time Frame: 6. hour
none - mild- moderate- severe
6. hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Diskapi Training and Research Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 10, 2020

Primary Completion (ACTUAL)

June 10, 2020

Study Completion (ACTUAL)

July 10, 2020

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (ACTUAL)

March 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Urinery Catheter Discomfort

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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