Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS

NCT05604599 | Completed Phase 4

• 1 other identifier: IRB 00012367-22-011-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Endoscopic Sinus Surgery; Premedication; Analgesia

Keywords

Dexmedetomidine; Intranasal; Intravenous

Outcome Measures

Primary Outcomes (2)

• Improving quality of the operative field.

  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.

  during surgery (intraoperatively) 2 hours

• Amount of atropine consumption

  The total amount of atropine consumed will be recorded

  First 24 hours postoperatively

Secondary Outcomes (5)

• Hemodynamics(Heart rate (bpm))

  2 hours

• Hemodynamics(Mean arterial blood pressure mm Hg))

  2 hours

• Pain score

  First 24 hours postoperatively

• Adverse events

  24 postoperatively

• hemostatic stuffing

  24 hours postoperatively

Study Arms (2)

Intranasal dexmedetomidine group

ACTIVE COMPARATOR

30 patients will receive 1µg/kg dexmedetomidine diluted in 10ml 0.9% saline intranasally preoperative administered to each naris as drops 45 -60 min before the operation +infusion saline.

Drug: Intranasal dexmedetomidine

Intravenous dexmedetomidine group

ACTIVE COMPARATOR

30 patients will receive a dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia + intranasal saline.

Drug: Intravenous dexmedetomidine

Interventions

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

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

Intranasal dexmedetomidine group

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.

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

Intravenous dexmedetomidine group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Facualty of Medicine(Damietta), Al Azhar University

Damietta, 34711, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Propofol; Fentanyl; Isoflurane; Oxygen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: November 10, 2022
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)