Condition 1: postprocedural pain. Condition 2: Bladder Cancer. Other acute postprocedural pain Malignant neoplasm of bladder
Conditions
Interventions
Intervention 1: Intervention group: Intervention group 1 – DexmedetomidineIn this group, patients undergo general anesthesia for radical cystectomy surgery. Dexmedetomidine is administered as follows:
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients with bladder cancer who are candidates for open radical cystectomy. Ability to comply with postoperative follow-up according to the study protocol. Written informed consent to participate in the study. ASA physical status class I–III. Age 18 years or older.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or allergy to dexmedetomidine, remifentanil, or other drugs used in the study. Unwillingness to continue participation in the study at any stage. Pregnancy or breastfeeding. Cognitive or psychiatric disorders that prevent providing informed consent. Chronic opioid use or substance abuse. Severe uncontrolled cardiac, hepatic, or renal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of postoperative pain intensity at recovery room, 6 hours after surgery, 12 hours after surgery, and 24 hours after surgery. Timepoint: Measurement of pain intensity using the Visual Analogue Scale for pain. Method of measurement: Measurement of pain intensity using the Visual Analogue Scale for pain (visual pain assessment ruler).;Total consumption of rescue analgesic during the first 24 hours after surgery. Timepoint: Recording the amount of rescue analgesic consumption during the first 24 hours after the end of surgery. Method of measurement: Measurement of the total amount of administered rescue analgesic expressed as milligrams of morphine equivalent based on nursing and medical records of the patient.;Time to first request for analgesic after surgery. Timepoint: Recording the time from the end of surgery to the patient’s first request for analgesic medication. Method of measurement: Measurement of the time interval in minutes using the recorded time of the end of surgery and the time of the first analgesic request in the patient’s nursing record. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of postoperative nausea and vomiting during the first 24 hours after surgery. Timepoint: Assessment of the occurrence of nausea and vomiting at regular time intervals during the first 24 hours after the end of surgery. Method of measurement: Recording the presence or absence of nausea and vomiting based on the patient’s report and nursing observations documented in the medical record.;Changes in blood pressure and heart rate during the first 24 hours after surgery. Timepoint: Measurement and recording of blood pressure and heart rate at regular time intervals during the first 24 hours after the end of surgery. Method of measurement: Measurement of blood pressure and heart rate using routine patient monitoring and recording the values in the nursing and medical records.;Time to awakening from anesthesia after the end of surgery. Timepoint: From the time of discontinuation of anesthetic drugs until the patient’s full awakening after the end of surgery. Method of measurement: Recording the time interval from discontinuation of anesthetic drugs to the patient’s full awakening based on clinical observations and documentation in the medical record, expressed in minutes.;Duration of the patient’s stay in the recovery room after surgery. Timepoint: From the time of the patient’s admission to the recovery room until discharge from the recovery room after the end of surgery. Method of measurement: Recording the patient’s admission and discharge times from the recovery room based on nursing and medical records, and calculating the duration of stay in minutes. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaede Karimian
Shahid Beheshti University of Medical Sciences
Outcome results
None listed