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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05911776
Other study ID # KFSIRB200-3
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 30, 2023
Est. completion date February 27, 2024

Study information

Verified date March 2024
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.


Description:

Dexmedetomidine (DEX) is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes DEX primarily sedative and anxiolytic. The elimination half-life of DEX (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration. Potentially desirable effects include decreased requirements for other anesthetics and analgesics.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 27, 2024
Est. primary completion date February 27, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age 18 to 65 years - Both sexes - American Society of Anesthesiologists (ASA) physical status classification I or II. - Undergo turbinate surgery Exclusion Criteria: - Patients with a body mass index > 30 kg/m2 existing or recent significant disease. - Contraindications to the use of dexmedetomidine . - History or presence of a significant disease significant cardiovascular disease risk factors. - Significant coronary artery disease or any known genetic predisposition. - History of any kind of drug allergy, - Drug abuse. - Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening. - Known systemic disease requiring the use of anticoagulants, - Patients with a history of previous turbinate surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nasal packing Dexmedetomidine
patients will receive nasal packing Dexmedetomidine (1.5 µg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline.
Intravenous Dexmedetomidine
patients will receive 0.5 µg/kg bolus over 10 min then 0.1- 0.4 µg/kg Intravenous infusion Dexmedetomidine and nasal packing with saline.

Locations

Country Name City State
Egypt Karelsheikh University Hospital Kafr Ash Shaykh Karelsheikh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of intraoperative blood loss Measuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges. Intraoperative up to 6hours
Secondary Pain score Visual analogue scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain) 24 hours postoperative
Secondary Quality of intraoperative surgical field Quality of intraoperative surgical field during after turbinate surgery will be evaluated by the surgeons by rating the amount of bleeding according to a 6-point scale by Formmer's scores of surgical field quality (0= no bleeding; 1= bleeding, so mild it was not even a surgical nuisance; 2= moderate bleeding, a nuisance but without interference; 3= moderate bleeding that moderately compromised surgical; 4= bleeding, heavy but controllable, that significantly interfered; 5= massive uncontrollable bleeding) Intraoperative up to 6hours
Secondary Patient's general satisfaction Patients' satisfaction will be measured immediately postoperative and using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied. 24 hours postoperative
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