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

August 26, 2023 updated by: Osama Rehab, Tanta University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • ElGharbiaa
      • Tanta, ElGharbiaa, Egypt, 31528
        • Tanta University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aminophylline group
Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.
Drug: Aminophylline group
Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.
Placebo Comparator: Control group
Patients will receive 50 ml normal saline over 30 minutes.
Drug: normal saline
Patients will receive 50 ml normal saline over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two hours after discontinuation of anesthetics

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative period
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.
Intraoperative period
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.
60 minutes after tracheal extubation
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.
Two hours after tracheal extubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2023

Primary Completion (Actual)

August 25, 2023

Study Completion (Actual)

August 25, 2023

Study Registration Dates

First Submitted

February 11, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 26, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR58/1/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon reasonable request from the corresponding after 6 mon from publication

IPD Sharing Time Frame

after 6 mon from publication

IPD Sharing Access Criteria

The data will be available upon reasonable request from the corresponding

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dexmedetomidine

Clinical Trials on Aminophylline group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe