Combined Dexmedetomidine and Glycopyrrolate Therapy

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05013320
Collaborator
(none)
0
2
16

Study Details

Study Description

Brief Summary

Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dexmedetomidine only

dexmedetomidine is administered during the surgery

Drug: Dexmedetomidine
Dexmedetomidine administration during the surgery.

Experimental: Combined dexmedetomidine and glycopyrrolate

glycopyrrolate and dexmedetomidine are administered during the surgery

Drug: Glycopyrrolate + dexmedetomidine
Intravenous glycopyrrolate before anesthetic induction. Dexmedetomidine administration during the surgery.

Outcome Measures

Primary Outcome Measures

  1. The incidence of catheter-related bladder discomfort [0 minute after entering the post-anesthetic care unit]

    No = not complaining of bladder discomfort on asking; Mild = report discomfot only on questioning; Moderate: report without questioning without behavior responses; Severe = report without questioniing accompanied by behavior responses. Mild, Moderate, Severe bladder discomfort is defined to have catheter-related bladder discomfort

Secondary Outcome Measures

  1. Emergence agitation [0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit]

    (1)calm (2)slightly agitated but consolable (3)moderately agitated and inconsolable (4)severely agitated and highly inconsolable

  2. Delirium [0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit]

    (1)acute and fluctuating changes in mental status (2)inattention (3)disorganized or incoherent thinking (4)altered level of consciousness. (1),(2) and (3), (1),(2), and (4), or (1)(2)(3)and (4) are defined to have deilrium.

  3. Postoperative pain [0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit]

    numerical rating scale (0=no pain to 10=worst pain imaginable)

  4. Sedation score [0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit]

    (1)anxious, agitated or restless (2)cooperative, oriented and trranquil (3)responds to commands, asleep (4)brisk response to light glabellar taps or oud noise (5)sluggish response to light glabellar taps or loud noise (6)noresponse

  5. Dry mouth [0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit]

    yes or no

  6. postoperative nausea and vomiting [0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit]

    yes or no

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • American Society of Anesthesiologists physical status I and II

  • elective transurethral resection of bladder tumor under general anesthesia

Exclusion Criteria:
  • arrhythmia

  • bladder outflow obstruction

  • overacitve bladder

  • end stage renal disease

  • neurogenic bladder

  • morbid obesity

  • psychiatric disorder

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kangbuk Samsung Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eunah Cho, MD, Assistant professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier:
NCT05013320
Other Study ID Numbers:
  • DEXLYCO
First Posted:
Aug 19, 2021
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021