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Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02252445
Enrollment
82
Registered
2014-09-30
Start date
2014-11-30
Completion date
2015-01-31
Last updated
2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Catheter Site Discomfort, Complications, Urinary Bladder Neoplasms

Brief summary

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

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.

Interventions

DRUGPropofol

Propofol will be administered.

DRUGSevoflurane

Sevoflurane will be administered.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Catheter-related Bladder Discomfort1 hour postoperativelyCatheter-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.

Secondary

MeasureTime frameDescription
Hemodynamic Parameters0, 1, 5, 10 minute postoperativelyMean 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.
Nausea0, 1, 6 and 24 hour postoperativelyNausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Vomiting0, 1, 6 and 24 hour postoperativelyVomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Dry Mouth0, 1, 6 and 24 hour postoperativelyDry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
Catheter-related Bladder Discomfort0, 6 and 24 hour postoperativelyCatheter-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.
Blurred Vision0, 1, 6 and 24 hour postoperativelyBlurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
Dizziness0, 1, 6 and 24 hour postoperativelyDizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
Analgesics0, 1, 6 and 24 hour postoperativelyThe amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
Flushing0, 1, 6 and 24 hour postoperativelyFlushing will be measured at 0, 1, 6 and 24 hour postoperatively.

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Propofol
Propofol will be administered as the anesthetic maintenance agent. Propofol: Propofol will be administered.
41
Sevoflurane
Sevoflurane will be administered as the anesthetic maintenance agent. Sevoflurane: Sevoflurane will be administered.
41
Total82

Baseline characteristics

CharacteristicPropofolSevofluraneTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
22 Participants22 Participants44 Participants
Age, Categorical
Between 18 and 65 years
19 Participants19 Participants38 Participants
Region of Enrollment
Korea, Republic of
41 participants41 participants82 participants
Sex: Female, Male
Female
9 Participants11 Participants20 Participants
Sex: Female, Male
Male
32 Participants30 Participants62 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 410 / 41
serious
Total, serious adverse events
0 / 410 / 41

Outcome results

Primary

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

Population: Patients with score \>0 were counted.

ArmMeasureValue (NUMBER)
PropofolCatheter-related Bladder Discomfort35 participants
SevofluraneCatheter-related Bladder Discomfort24 participants
Secondary

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

Population: Patients infused with tramadol were counted.

ArmMeasureValue (NUMBER)
PropofolAnalgesics22 participants
SevofluraneAnalgesics13 participants
Secondary

Blurred Vision

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

Time frame: 0, 1, 6 and 24 hour postoperatively

Population: Patients with blurred vision were counted.

ArmMeasureValue (NUMBER)
PropofolBlurred Vision0 participants
SevofluraneBlurred Vision0 participants
Secondary

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

Population: Patients with score \>0 will be counted.

ArmMeasureValue (NUMBER)
PropofolCatheter-related Bladder Discomfort38 participants
SevofluraneCatheter-related Bladder Discomfort27 participants
Secondary

Dizziness

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

Time frame: 0, 1, 6 and 24 hour postoperatively

Population: Patients with dizziness were counted.

ArmMeasureValue (NUMBER)
PropofolDizziness0 participants
SevofluraneDizziness0 participants
Secondary

Dry Mouth

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

Time frame: 0, 1, 6 and 24 hour postoperatively

Population: Patients with dry mouth were counted.

ArmMeasureValue (NUMBER)
PropofolDry Mouth2 participants
SevofluraneDry Mouth2 participants
Secondary

Flushing

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

Time frame: 0, 1, 6 and 24 hour postoperatively

Population: Patients with flushing were counted.

ArmMeasureValue (NUMBER)
PropofolFlushing0 participants
SevofluraneFlushing0 participants
Secondary

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

ArmMeasureValue (MEAN)Dispersion
PropofolHemodynamic Parameters90 mmHgStandard Deviation 24
SevofluraneHemodynamic Parameters88 mmHgStandard Deviation 27
Secondary

Nausea

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

Time frame: 0, 1, 6 and 24 hour postoperatively

Population: Patients with nausea were counted.

ArmMeasureValue (NUMBER)
PropofolNausea2 participants
SevofluraneNausea3 participants
Secondary

Vomiting

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

Time frame: 0, 1, 6 and 24 hour postoperatively

Population: Patients with vomiting were counted.

ArmMeasureValue (NUMBER)
PropofolVomiting2 participants
SevofluraneVomiting1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026