NCT05705050

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

January 21, 2023

Last Update Submit

June 24, 2023

Conditions

AminophyllinePainUreterocopic Lithotripsy

Keywords

AminophyllinePostoperative PainUreterocopic Lithotripsy

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Visual analogue score (VAS) score: will be measured on arrival to PACU, at 30 minutes, 1 hour, 2 hour, 6, 12 and 24 hour after surgery.

    In post anesthesia care unit (PACU)

Secondary Outcomes (3)

  • Intensity of pain

    24 hour after surgery

  • Total amount of opioid dose

    24 hour after surgery

  • The incidence of postoperative adverse reactions

    24 hour after surgery

Study Arms (2)

Aminophylline group

EXPERIMENTAL

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.

Drug: Aminophylline group

Control group

PLACEBO COMPARATOR

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

Other: Control group

Interventions

Aminophylline groupDRUG

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.

Aminophylline group
Control groupOTHER

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

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
  • Pregnancy or lactation.
  • Patients with a history of allergy to aminophylline.
  • Coffee consumption (more than 2 cups/day)
  • Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants.
  • Short procedures less than 30 minutes or procedures not requiring D-J stent placement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Location

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Intensive Care and Pain Medicine

Study Record Dates

First Submitted

January 21, 2023

First Posted

January 30, 2023

Study Start

February 15, 2023

Primary Completion

June 18, 2023

Study Completion

June 19, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will be available 6 months after publication
Access Criteria
The data will be available upon a reasonable request from the corresponding author

Locations

EG(1)