NCT05738135

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 25, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
Last Updated

August 29, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

February 11, 2023

Last Update Submit

August 26, 2023

Conditions

AminophyllineDexmedetomidineFunctional Endoscopic Sinus Surgery

Keywords

AminophyllineDexmedetomidineHemodynamicsRecoveryFunctional Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

  • Time to extubation

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

    Two hours after discontinuation of anesthetics

Secondary Outcomes (4)

  • Intraoperative heart rate

    Intraoperative period

  • Intraoperative mean arterial blood pressure

    Intraoperative period

  • Postoperative sedation score

    60 minutes after tracheal extubation

  • Time to discharge from post anesthesia care unit

    Two hours after tracheal extubation.

Study Arms (2)

Aminophylline group

EXPERIMENTAL

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

Drug: Aminophylline group

Control group

PLACEBO COMPARATOR

Patients will receive 50 ml normal saline over 30 minutes.

Drug: normal saline

Interventions

Aminophylline groupDRUG

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

Aminophylline group
normal salineDRUG

Patients will receive 50 ml normal saline over 30 minutes.

Control group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31528, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, 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

February 11, 2023

First Posted

February 21, 2023

Study Start

February 25, 2023

Primary Completion

August 25, 2023

Study Completion

August 25, 2023

Last Updated

August 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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

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

Locations

EG(1)