Combined Dexmedetomidine and Glycopyrrolate Therapy

Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Bladder Irritable
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Glycopyrrolate + dexmedetomidine

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of catheter-related bladder discomfort	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	0 minute after entering the post-anesthetic care unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence agitation	(1)calm (2)slightly agitated but consolable (3)moderately agitated and inconsolable (4)severely agitated and highly inconsolable	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Delirium	(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.	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Postoperative pain	numerical rating scale (0=no pain to 10=worst pain imaginable)	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Sedation score	(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	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Dry mouth	yes or no	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
postoperative nausea and vomiting	yes or no	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; Dexmedetomidine; Glycopyrrolate
• Other Study ID Numbers: DEXLYCO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No