Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2010-08-31
2014-08-31
Brief Summary
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The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and (3) surgery under spinal anesthesia. All the patients where (1) opioids were administered during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder catheterization was perform during the surgery were excluded from the study.
The participants were randomly divided into the study and control groups. No oral premedication was administered. All the patients were asked to empty their urinary bladders before arrival to the operating theatre. When the standard monitoring (continuous electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric 0.5% solution of bupivacaine hydrochloride was performed.
In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride was administered intramuscularly. The decresed intravascular volume was corrected with cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay scale, level of sedationt was obtained with midazolam and/or propofol. All the participants received a questionaire in which we asked the questions about (1) the duration of anesthesia, (2) the time of micturition, (3) the time when discomfort or pain appeared in the lower abdomen, (4) the incidence of the urinary bladder catheterization and time to catheterization. On the next day after the surgery the questionaires were collected. In cases, when the patient's dischaged from the hospital was planned during the weekend, he or she was asked to pass on the questionaire to the nurses.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Drotaverine
40 mg of drotaverine hydrochloride administered intramuscularly just after the proper level of spinal anesthesia was achieved.
No interventions assigned to this group
Control
Without intramuscular administration of drotaverine hydrochloride.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* surgery under spinal anesthesia,
* no previous history of urological problems.
Exclusion Criteria
* need for urinary bladder catheterization during surgery,
* conversion to general anesthesia.
18 Years
40 Years
ALL
No
Sponsors
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Military Institute od Medicine National Research Institute
OTHER
Responsible Party
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Dariusz Tomaszewski
MD, PhD
Locations
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Military Institute of Medicine
Warsaw, , Poland
Countries
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References
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Tomaszewski D, Balkota M. Intramuscular Administration of Drotaverine Hydrochloride Decreases Both Incidence of Urinary Retention and Time to Micturition in Orthopedic Patients under Spinal Anesthesia: A Single Blinded Randomized Study. Biomed Res Int. 2015;2015:926953. doi: 10.1155/2015/926953. Epub 2015 Jun 21.
Other Identifiers
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06101968-1
Identifier Type: -
Identifier Source: org_study_id
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