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Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05911776
Enrollment
60
Registered
2023-06-22
Start date
2023-06-30
Completion date
2024-02-27
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Packing, Dexmedetomidine, Turbinate

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.

Interventions

DRUGNasal packing Dexmedetomidine

patients will receive nasal packing Dexmedetomidine (1.5 μg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline.

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.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of intraoperative blood lossIntraoperative up to 6hoursMeasuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges.

Secondary

MeasureTime frameDescription
Pain score24 hours postoperativeVisual analogue scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)
Quality of intraoperative surgical fieldIntraoperative up to 6hoursQuality 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 satisfaction24 hours postoperativePatients' satisfaction will be measured immediately postoperative and using a five-point Likert scale consisting of very dissatisfied, dissatisfied, unsure, satisfied, and very satisfied.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026