Combined Dexmedetomidine and Glycopyrrolate Therapy

Not Applicable

Withdrawn

• Conditions: Bladder Irritable
• Interventions: Drug: Glycopyrrolate + dexmedetomidine; Drug: Dexmedetomidine

• Registration Number: NCT05013320
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-13
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-17
• Last Update Submitted: 2021-08-17
• Study First Posted: 2021-08-19
• Last Update Posted: 2021-08-19
• Study Start: 2021-09-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined dexmedetomidine and glycopyrrolate	Glycopyrrolate + dexmedetomidine	glycopyrrolate and dexmedetomidine are administered during the surgery
Dexmedetomidine only	Dexmedetomidine	dexmedetomidine is administered during the surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Dry mouth	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit	yes or no
postoperative nausea and vomiting	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit	yes or no
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
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.
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)