Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

NCT05911776 | Completed Phase 4

• 1 other identifier: KFSIRB200-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Packing; Dexmedetomidine; Turbinate

Outcome Measures

Primary Outcomes (1)

• Amount of intraoperative blood loss

  Measuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges.

  Intraoperative up to 6hours

Secondary Outcomes (3)

• Pain score

  24 hours postoperative

• Quality of intraoperative surgical field

  Intraoperative up to 6hours

• Patient's general satisfaction

  24 hours postoperative

Study Arms (2)

Group NP (nasal packing Dexmedetomidine)

ACTIVE COMPARATOR

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

Drug: Nasal packing Dexmedetomidine

Group IV (Intravenous Dexmedetomidine)

ACTIVE COMPARATOR

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.

Drug: Intravenous Dexmedetomidine

Interventions

Nasal packing Dexmedetomidine DRUG

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

Group NP (nasal packing Dexmedetomidine)

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.

Group IV (Intravenous Dexmedetomidine)

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Karelsheikh University Hospital

Kafr ash Shaykh, Karelsheikh, 33516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 22, 2023
• Study Start: June 30, 2023
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

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

Locations

EG (1)