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

NCT04314050 | Completed

• 1 other identifier: Urinery Catheter Discomfort
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Related Complication

Keywords

dexmedetomidine; tramadol; catheter-related bladder discomfort

Outcome Measures

Primary Outcomes (4)

• the severity of CRBD

  none - mild- moderate- severe

  0. hour

• the severity of CRBD

  none - mild- moderate- severe

  1. hour

• the severity of CRBD

  none - mild- moderate- severe

  3. hour

• the severity of CRBD

  none - mild- moderate- severe

  6. hour

Secondary Outcomes (1)

• 11-point numerical rating scale (NRS)

  24 hours

Study Arms (3)

tramadol

ACTIVE COMPARATOR

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

dexmedetomidine

ACTIVE COMPARATOR

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

control

PLACEBO COMPARATOR

1 gr paracetamol will perform intraoperatively

Other: control

Interventions

Tramadol DRUG

tramadol and paracetamol will perform

Also known as: Contramal

tramadol

Dexmedetomidine DRUG

dexmedetomidine and paracetamol will perform

Also known as: precedex

dexmedetomidine

control OTHER

paracetamol will perform

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: male patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Diskapi Training and Research Hospital: lead

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30603826 BACKGROUND

• 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.

  PMID: 18653496 BACKGROUND

• 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.

  PMID: 25485879 BACKGROUND

• Akca B, Aydogan-Eren E, Canbay O, Karagoz AH, Uzumcugil F, Ankay-Yilbas A, Celebi 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.

  PMID: 26739975 BACKGROUND

• 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.

  PMID: 30572837 RESULT

MeSH Terms

Interventions

Tramadol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fatma Özkan Sipahioglu, specialist

  Ankara Diskapi Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: March 10, 2020
• Primary Completion: June 10, 2020
• Study Completion: July 10, 2020
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

TU (1)