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NCT Number: NCT05705050

Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

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.

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Key information

Conditions

Aminophylline Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Ureterocopic Lithotripsy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Aminophylline group

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

Other

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

Primary outcomes

  1. Intensity of pain

    Time frame: In post anesthesia care unit (PACU)

    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.

Secondary outcomes

  1. Intensity of pain

    Time frame: 24 hour after surgery

    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.

  2. Total amount of opioid dose

    Time frame: 24 hour after surgery

    If Patients reported VAS score more than 3, they will receive intravenous 0.5 mg /kg pethidine. All patients will be observed in PACU for at least 2 hour and in the ward on the day of surgery for confirming any side effects or complications.

  3. The incidence of postoperative adverse reactions

    Time frame: 24 hour after surgery

    the incidence of adverse reactions, such as arrhythmia, postoperative nausea and vomiting (PONV) and postoperative lightheadedness will be recorded in both groups.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2023
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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