CompletedNCT02252445Updated Sep 1, 2016Results posted

Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

An interventional study of Propofol and Sevoflurane in Catheter Site Discomfort, Complications and Anesthesia, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-01.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 82
Allocation: Randomized
Ages: 19 Years to 80 Years
Sex: All

Study summary

The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Read the detailed description

The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent. Propofol and desflurane are known to block the muscarinic receptor in different ways.

The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Conditions studied

Catheter Site Discomfort
Complications
Anesthesia
Urinary Bladder Neoplasms

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Urinary Bladder Neoplasms 1,616

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 82 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

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Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients scheduled for transurethral bladder excision under general anesthesia
ASA I-III

Exclusion criteria

Exclusion Criteria:

Foley catheter less than 18 Fr.
Patients with obstruction of urinary tract
Patients with neurogenic bladder
Patients with severe obesity
Patients with neurologic disorder
Patients with chronic pain
Patients with allergic history to propofol or sevoflurane

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 82 participants (actual)

Study arms

Active comparator
Propofol
Propofol will be administered as the anesthetic maintenance agent.
Drug: Propofol
Experimental
Sevoflurane
Sevoflurane will be administered as the anesthetic maintenance agent.
Drug: Sevoflurane

Interventions

DrugPropofol
Propofol will be administered.
DrugSevoflurane
Sevoflurane will be administered.

What researchers measure

Primary outcomes

Catheter-related Bladder Discomfort
Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score \>0 will be counted.
Time frame: 1 hour postoperatively

Secondary outcomes

Catheter-related Bladder Discomfort
Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score \>0 will be counted.
Time frame: 0, 6 and 24 hour postoperatively
Hemodynamic Parameters
Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.
Time frame: 0, 1, 5, 10 minute postoperatively
Nausea
Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Time frame: 0, 1, 6 and 24 hour postoperatively
Vomiting
Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Time frame: 0, 1, 6 and 24 hour postoperatively
Dry Mouth
Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
Time frame: 0, 1, 6 and 24 hour postoperatively
Flushing
Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
Time frame: 0, 1, 6 and 24 hour postoperatively
Blurred Vision
Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
Time frame: 0, 1, 6 and 24 hour postoperatively
Dizziness
Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
Time frame: 0, 1, 6 and 24 hour postoperatively
Analgesics
The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
Time frame: 0, 1, 6 and 24 hour postoperatively

Results

Posted Sep 1, 2016

Participant flow

Participant flow — Overall Study
Milestone	Propofol	Sevoflurane
Started	41	41
Completed	41	41
Not completed	0	0

Outcome measures

PrimaryCatheter-related Bladder Discomfort

Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score \>0 will be counted.

Time frame:: 1 hour postoperatively
Reported as:: Number · participants

Catheter-related Bladder Discomfort
participants	Propofol	Sevoflurane
Catheter-related Bladder Discomfort	35	24

SecondaryCatheter-related Bladder Discomfort

Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score \>0 will be counted.

Time frame:: 0, 6 and 24 hour postoperatively
Reported as:: Number · participants

Catheter-related Bladder Discomfort
participants	Propofol	Sevoflurane
Catheter-related Bladder Discomfort	38	27

SecondaryHemodynamic Parameters

Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.

Time frame:: 0, 1, 5, 10 minute postoperatively
Reported as:: Mean · mmHg

Hemodynamic Parameters
mmHg	Propofol	Sevoflurane
Hemodynamic Parameters	90 ± 24	88 ± 27

SecondaryNausea

Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.

Time frame:: 0, 1, 6 and 24 hour postoperatively
Reported as:: Number · participants

Nausea
participants	Propofol	Sevoflurane
Nausea	2	3

SecondaryVomiting

Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.

Time frame:: 0, 1, 6 and 24 hour postoperatively
Reported as:: Number · participants

Vomiting
participants	Propofol	Sevoflurane
Vomiting	2	1

SecondaryDry Mouth

Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.

Time frame:: 0, 1, 6 and 24 hour postoperatively
Reported as:: Number · participants

Dry Mouth
participants	Propofol	Sevoflurane
Dry Mouth	2	2

SecondaryFlushing

Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.

Time frame:: 0, 1, 6 and 24 hour postoperatively
Reported as:: Number · participants

Flushing
participants	Propofol	Sevoflurane
Flushing	0	0

SecondaryBlurred Vision

Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.

Time frame:: 0, 1, 6 and 24 hour postoperatively
Reported as:: Number · participants

Blurred Vision
participants	Propofol	Sevoflurane
Blurred Vision	0	0

SecondaryDizziness

Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.

Time frame:: 0, 1, 6 and 24 hour postoperatively
Reported as:: Number · participants

Dizziness
participants	Propofol	Sevoflurane
Dizziness	0	0

SecondaryAnalgesics

The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.

Time frame:: 0, 1, 6 and 24 hour postoperatively
Reported as:: Number · participants

Analgesics
participants	Propofol	Sevoflurane
Analgesics	22	13

Adverse events

Collected over 0 h, 1 h, 6 h, 24 h, 6 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Propofol	—	0/41 (0%)	0/41 (0%)
Sevoflurane	—	0/41 (0%)	0/41 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Propofol	Sevoflurane	Total
<=18 years	0	0	0
Between 18 and 65 years	19	19	38
>=65 years	22	22	44

Sex: Female, Male
Sex: Female, Male(Participants)	Propofol	Sevoflurane	Total
Female	9	11	20
Male	32	30	62

Region of Enrollment
Region of Enrollment(participants)	Propofol	Sevoflurane	Total
Korea, Republic of	41	41	82

Study locations

1 site

Seolu National University of Hospital
Seoul, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02252445
Lead sponsor: Seoul National University Hospital
Responsible party: Sponsor
First posted: Sep 30, 2014
Start date: Nov 2014
Primary completion: Jan 2015
Completion: Jan 2015
Results posted: Sep 1, 2016
Last update: Sep 1, 2016

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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