Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

Dexmedetomidine Clinical Trial

Official title:

Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries: A Randomized Double-Blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05911776
• Other study ID #: KFSIRB200-3
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Dexmedetomidine
• Nasal Packing

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