Pre-emptive Analgesia Using Nebulized Ketamine Versus Nebulized Dexmedetomidine in Endoscopic Nasal Surgeries

NCT07056582 | Recruiting

• 1 other identifier: Soh-Med--25-4-08MS
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

this study aims to compare the efficacy of pre-emptive nebulized ketamine versus nebulized dexmedetomidine for post operative pain relief in endoscopic nasal surgery

Conditions

Nose Diseases

Outcome Measures

Primary Outcomes (1)

• This study aims to assess the efficacy of nebulized dexmedetomidine vs nebulized ketamine to achieve good postoperative pain management in patients undergoing endoscopic nasal surgeries.

  post operative pain management by VAS

  24 hours after operation

Study Arms (3)

group D : will receive dexmedetomidine

ACTIVE COMPARATOR

Patients will receive nebulized dexmedetomidine 50 μg (0.5 ml +normal saline 0.9% up to 3 ml) 15 minutes prior to the onset of surgery.

Drug: Dexmedetomidine

group K : will receive ketamine

ACTIVE COMPARATOR

patients will receive nebulized ketamine 50 mg (1 ml + normal saline 0.9%up to 3 ml) 15 minutes prior to the onset of surgery.

Drug: Ketamine

group C: will receive .9% saline

PLACEBO COMPARATOR

Patients will receive nebulized normal saline 0.9% (3 ml) 15 minutes prior to the onset of surgery.

Drug: 0.9%sodium chloride

Interventions

Dexmedetomidine DRUG

patients in this group will receive nebulized Dexmedetomidine before onset of surgery

group D : will receive dexmedetomidine

Ketamine DRUG

patients in this group will receive nebulized ketamine before onset of surgery

group K : will receive ketamine

0.9%sodium chloride DRUG

patients in this group will receive nebulized 0.9% normal saline before onset of surgery

group C: will receive .9% saline

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients between the ages of 20 and 60,
• both sexes,
• American Society of Anesthesiologists physical status I to II
• BMI ≥18≤30 kg/m²

You may not qualify if:

• Patient refusal.
• patients with advanced respiratory, renal, hepatic, neurological, or psychiatric disease, pregnant or nursing women.
• patients with a history of allergies to any study drugs.
• patients who had used central nervous system depressants or analgesics within the previous 24 hours.
• patients with hypertension, hypotension, or bradycardia.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

• Parthasarathy S, Krishnapriyanka KJ, Saravanan B. Effectiveness of pre-emptive nerve block on opioid consumption in patients undergoing nasal surgery under general anaesthesia: A double-blinded randomised controlled study. Indian J Anaesth. 2022 Feb;66(2):133-139. doi: 10.4103/ija.ija_813_21. Epub 2022 Feb 24.

  PMID: 35359478 RESULT

• Prasant NVSN, Mohapatro S, Jena J, Moda N. Comparison of Preoperative Nebulization with 4% Lignocaine and Ketamine in Reduction of Incidence of Postoperative Sore Throat. Anesth Essays Res. 2021 Jul-Sep;15(3):316-320. doi: 10.4103/aer.aer_105_21. Epub 2022 Feb 14.

  PMID: 35320968 RESULT

• Cai Y, Xu H, Yan J, Zhang L, Lu Y. Molecular targets and mechanism of action of dexmedetomidine in treatment of ischemia/reperfusion injury. Mol Med Rep. 2014 May;9(5):1542-50. doi: 10.3892/mmr.2014.2034. Epub 2014 Mar 10.

  PMID: 24627001 RESULT

MeSH Terms

Conditions

Nose Diseases

Interventions

Dexmedetomidine; Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Ahmed T Abdelhameed, Resident

CONTACT

01012833899; ahmedthanocloser460@gmail.com

Hala M Hashem, Professor

CONTACT

01004385249

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident , Anesthesia , Surgical Icu , Pain management Faculty of Medicine Sohag university

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: April 14, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

EG (1)