Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

Phase 4

Completed

• Conditions: Turbinate; Nasal Packing; Dexmedetomidine
• Interventions: Drug: Nasal packing Dexmedetomidine; Drug: Intravenous Dexmedetomidine

• Registration Number: NCT05911776
• Lead Sponsor: Kafrelsheikh University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-06-10
• Study First Posted: 2023-06-22
• Study Start: 2023-06-30
• Primary Completion: 2024-02-27
• Study Completion: 2024-02-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-09
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18 to 65 years
• Both sexes
• American Society of Anesthesiologists (ASA) physical status classification I or II.
• Undergo turbinate surgery

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group NP (nasal packing Dexmedetomidine)	Nasal packing Dexmedetomidine	Patients will receive nasal packing Dexmedetomidine (1.5 μg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline.
Group IV (Intravenous Dexmedetomidine)	Intravenous Dexmedetomidine	Patients will receive 0.5 μg/kg bolus over 10 min then 0.1- 0.4 μg/kg IV infusion Dexmedetomidine and nasal packing with saline.

Primary Outcome Measures

Name	Time	Method
Amount of intraoperative blood loss	Intraoperative up to 6hours	Measuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges.

Secondary Outcome Measures

Name	Time	Method
Pain score	24 hours postoperative	Visual analogue scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)
Quality of intraoperative surgical field	Intraoperative up to 6hours	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)
Patient's general satisfaction	24 hours postoperative	Patients' satisfaction will be measured immediately postoperative and using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.

Trial Locations

Locations (1)

Karelsheikh University Hospital; 🇪🇬 Kafr Ash Shaykh, Karelsheikh, Egypt