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NCT Number: NCT05738135

Aminophylline on Recovery in Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia

This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery.

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Key information

Conditions

Aminophylline Dexmedetomidine Functional Endoscopic Sinus Surgery

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, ElGharbiaa, 31528, Egypt

About this study

Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects of anaesthetic and analgesic agents

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged between 18 to 50 years, have American society of anesthesiology (ASA) physical status I - II and scheduled for elective FESS under general anesthesia and receiving dexmedetomidine infusion for controlled hypotension during surgery.

Exclusion criteria

  • Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
  • Pregnancy or lactation.
  • Patients with a history of allergy to aminophylline.
  • Patients with recurrent sinus surgery, hypertension.

Treatment and study plan

Aminophylline group

Drug

Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.

normal saline

Drug

Patients will receive 50 ml normal saline over 30 minutes.

Primary outcomes

  1. Time to extubation

    Time frame: Two hours after discontinuation of anesthetics

    Extubation time, defined as the interval between the discontinuation of anesthetics to safe tracheal extubation.

Secondary outcomes

  1. Intraoperative heart rate

    Time frame: Intraoperative period

    Heart rate will be recorded preoperatively (baseline), after loading dose of dexmedetomidine, after intubation, every 5 minutes during the study drug infusion, then every 15 minutes until end of surgery.

  2. Intraoperative mean arterial blood pressure

    Time frame: Intraoperative period

    Mean arterial blood pressure will be recorded preoperatively (baseline), after loading dose of dexmedetomidine, after intubation, every 5 minutes during the study drug infusion, then every 15 minutes until end of surgery.

  3. Postoperative sedation score

    Time frame: 60 minutes after tracheal extubation

    Postoperative sedation will be evaluated using the Ramsay sedation score as:

    1 = anxious, agitated, or restless 2= cooperative, oriented, and tranquil 3= responsive to commands 4= a sleep, but with brisk response to light, glabella tap, or loud auditory stimulus 5= a sleep, sluggish response to glabella tap, or auditory stimulus 6= a sleep, no response 6 is the highest sedation level Sedation score: will be measured at 15, 30, and 60 minutes after tracheal extubation.

  4. Time to discharge from post anesthesia care unit

    Time frame: Two hours after tracheal extubation.

    Time needed to achieve modified Aldrete Score ≥9 will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effect of Intravenous Aminophylline on Hemodynamics and Recovery of Patients Undergoing Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia: A Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Aug 29, 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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