The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine

NCT05828199 | Unknown Phase 1 DMC

• 1 other identifier: Ahmed Hegazy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.

Conditions

Nasal Polyps; Nasal Septum, Irregular; Functional Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• The postoperative pain

  Assessed by VAS score.As (VAS:0-10, where 0 = no pain, and 10 = worst possible pain). Before surgery, all patients will be a short education about VAS.

  from 0 hours to 24 hours after the procedure

Study Arms (2)

Dexmedtomidine group

ACTIVE COMPARATOR

About 40 patients will receive bolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr.

Drug: Dexmedetomidine

ketamin group

ACTIVE COMPARATOR

About 40 patients will receive a ketamine bolus dose (0.3 mg/kg IV slowly), then continuous infusion dose of ketamine (0.2 mg/kg/hr).

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.

ketamin group

Dexmedetomidine DRUG

bolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr

Dexmedtomidine group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 21 and 40 years of age, they with American Society of Anesthesiologists (ASA) physical status I-II and undergoing nasal and paranasal sinus surgery.

You may not qualify if:

• Refusal to join the study.
• Allergy to the drugs used in the study.
• Drug and/or alcohol abuse.
• Mental and psychiatric disorders.
• Emergency operations.
• Patients with systemic illnesses (eg, hypertension \[ SBP \>160 mm Hg\], diabetes mellitus.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Medicine, Al-Azhar University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Nasal Polyps

Interventions

Ketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Essam Ali, Professor

  Al-Azhar University, Faculty of medicine for boys

  STUDY CHAIR

Central Study Contacts

Ahmed Gamal, assist.lect

CONTACT

01099549595; ahmedgamal.226@azhar.edu.eg

Mohamed AboElSuod, Assist.prof

CONTACT

01091945931; mohamed.abdelgawad@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, intensive care and pain management Faculty of Medicine - Al-Azhar University

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 25, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 20, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

EG (1)