Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

NCT ID: NCT05705050

Last Updated: 2023-06-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-06-19

Brief Summary

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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.

Detailed Description

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Conditions

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Aminophylline Pain Ureterocopic Lithotripsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Aminophylline group

Intervention Type DRUG

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.

Control group

Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.

Interventions

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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.

Intervention Type DRUG

Control group

Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Osama Rehab

Lecturer of Anesthesiology, Intensive Care and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR19/1/23

Identifier Type: -

Identifier Source: org_study_id

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