Effect of Drug Clinical Trial
Official title:
The Effect of Oxycodone Hydrochloride on Catheter-related Bladder Discomfort After TURBT Under General Anesthesia
The purpose of this study is to investigate the effect of Oxycodone Hydrochloride on catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor after general anesthesia.
Status | Not yet recruiting |
Enrollment | 196 |
Est. completion date | November 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - More than 18 years old; - ASA I - III; - Plan to perform transurethral resection of bladder tumor under general anesthesia; ( - Agree to participate in this study and sign the informed consent form. Exclusion Criteria: - Refuse to participate in this study; - Emergency surgery; - Catheter was indwelling before operation; - Taking opioids for a long time before operation; - Previous history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis; - Unable to communicate due to coma, severe dementia or language disorder before operation; - Critical condition (ASA grade = IV before operation); Severe renal function damage (requiring renal replacement therapy); Severe liver function damage (child Pugh grade C); Acute stage of chronic obstructive pulmonary disease, severe asthma, severe pulmonary heart disease; - History of opioid allergy. |
Country | Name | City | State |
---|---|---|---|
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
Lead Sponsor | Collaborator |
---|---|
General Hospital of Ningxia Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of catheter-related bladder discomfort | CRBD is symptoms vary among patients from burning sensation and pain in the suprapubic and penile areas to urinary urgency.
4 grades 0:No discomfort Mild discomfort only reported upon questioning Moderate discomfort, urge to pass urine reported by the patient without questioning Severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong verbal responses, or attempt to pull out the catheter |
1 hour | |
Secondary | The incidence of Nausea and vomiting | Nausea refers to patients who have gastrointestinal symptoms but do not spit out stomach contents. Vomiting means that the patient has gastrointestinal symptoms and vomits stomach contents | 1 hour | |
Secondary | Degree of sedation | Ramsay evaluation | 1 hour | |
Secondary | Degree of pain | NRS | 1 hour | |
Secondary | the incidence of other complication | Respiratory depression, itching, shivering | 1 hour |
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