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

NCT ID: NCT05738135

Last Updated: 2023-08-29

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-25

Study Completion Date

2023-08-25

Brief Summary

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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.

Detailed Description

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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

Conditions

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Aminophylline Dexmedetomidine Functional Endoscopic Sinus Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Aminophylline group

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

Group Type EXPERIMENTAL

Aminophylline group

Intervention Type DRUG

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

Control group

Patients will receive 50 ml normal saline over 30 minutes.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Patients will receive 50 ml normal saline over 30 minutes.

Interventions

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Aminophylline group

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

Intervention Type DRUG

normal saline

Patients will receive 50 ml normal saline over 30 minutes.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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36264PR58/1/23

Identifier Type: -

Identifier Source: org_study_id

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