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NCT Number: NCT05604599

Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS

Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.

Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.

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Key information

Conditions

Functional Endoscopic Sinus Surgery Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Premedication Signs and Symptoms

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Facualty of Medicine(Damietta), Al Azhar University

Damietta, 34711, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 21 years of age.
  • Both genders.
  • American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus 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.
  • Any known genetic predisposition.
  • History of any kind of drug allergy.
  • Drug abuse.
  • Psychological or other emotional problems.
  • Special diet or lifestyle.
  • Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening.
  • Known systemic disease requiring the use of anticoagulants.
  • Any nasal disorders that may hinder nasal administration of the drugs as repeated nasal bleeding or nasal tumors.
  • Patients with a history of previous functional endoscopic sinus surgery.

Treatment and study plan

Intranasal dexmedetomidine

Drug

45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline

Other names: Propofol 2 mg/kg, fentanyl 1 µg/kg, Cis-atracurium 0.15mg / kg, Isoflurane 1-1.5% in 50% oxygen

Intravenous dexmedetomidine

Drug

patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline.

Other names: Propofol 2 mg/kg,, fentanyl 1 µg/kg , Cis-atracurium 0.15mg / kg and Isoflurane 1-1.5% in 50% oxygen

Primary outcomes

  1. Improving quality of the operative field.

    Time frame: during surgery (intraoperatively) 2 hours

    Quality of intraoperative surgical field during functional endoscopic sinus 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.

  2. Amount of atropine consumption

    Time frame: First 24 hours postoperatively

    The total amount of atropine consumed will be recorded

Secondary outcomes

  1. Hemodynamics(Heart rate (bpm))

    Time frame: 2 hours

    Heart rate (bpm), at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery.

  2. Hemodynamics(Mean arterial blood pressure mm Hg))

    Time frame: 2 hours

    Mean arterial blood pressure mm Hg) at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery.

  3. Pain score

    Time frame: First 24 hours postoperatively

    Pain measured with VAS: (visual analogue scale) will be assessed in post anesthesia care unit, 1, 2, 4, 6, 8, 12, 18, and 24hours postoperative.

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). patients are asked to rate their current level of pain by placing a mark on the line.

  4. Adverse events

    Time frame: 24 postoperatively

    Adverse events will be recorded such as nausea, vomiting, hypotension and bradycardia.

  5. hemostatic stuffing

    Time frame: 24 hours postoperatively

    The degree of adverse reactions of hemostatic stuffing after functional endoscopic sinus surgery will be also evaluated (1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate).

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2022
Registry last updated
Mar 14, 2023

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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