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NCT Number: NCT05911776

Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

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

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Key information

Conditions

Nasal Packing Dexmedetomidine Turbinate

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karelsheikh University Hospital

Kafr ash Shaykh, Karelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasal packing Dexmedetomidine

Drug

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

Intravenous dexmedetomidine

Drug

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.

Primary outcomes

  1. Amount of intraoperative blood loss

    Time frame: 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 outcomes

  1. Pain score

    Time frame: 24 hours postoperative

    Visual analogue scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)

  2. Quality of intraoperative surgical field

    Time frame: 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)

  3. Patient's general satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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