Clinical trial

Effect of Intraoperative Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy Surgeries

Name
36264PR19/1/23
Description
This study will be conducted to evaluate the effect of intraoperative systemic aminophylline infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with ureteric stent placement at the end of the procedure.
Trial arms
Trial start
2023-02-15
Estimated PCD
2023-06-18
Trial end
2023-06-19
Status
Completed
Treatment
Aminophylline group
Patients will receive 4 mg/kg aminophylline diluted in 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position.
Arms:
Aminophylline group
Control group
Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.
Arms:
Control group
Size
50
Primary endpoint
Intensity of pain
In post anesthesia care unit (PACU)
Eligibility criteria
Inclusion Criteria: * Aged between 18 to 50 years * American society of anesthesiology (ASA) physical status I - II * Body mass index (BMI) less than 30.0 kg/m2 * Scheduled for ureteroscopic lithotripsy surgery with D-J ureteric stent placement at the end of procedure * Under general anesthesia. Exclusion Criteria: 1. Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction. 2. Pregnancy or lactation. 3. Patients with a history of allergy to aminophylline. 4. Coffee consumption (more than 2 cups/day) 5. Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants. 6. Short procedures less than 30 minutes or procedures not requiring D-J stent placement.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-06-27

1 organization

1 product

3 indications

Organization
Tanta University
Indication
Aminophylline
Indication
Pain