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

NCT ID: NCT07056582

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-14

Study Completion Date

2025-10-20

Brief Summary

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

Detailed Description

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Conditions

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Nose Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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group D : will receive dexmedetomidine

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

group K : will receive ketamine

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.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

group C: will receive .9% saline

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

Group Type PLACEBO_COMPARATOR

0.9%sodium chloride

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Ketamine

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

Intervention Type DRUG

0.9%sodium chloride

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Thabet Abdelhameed

Resident , Anesthesia , Surgical Icu , Pain management Faculty of Medicine Sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed T Abdelhameed, Resident

Role: CONTACT

01012833899

Hala M Hashem, Professor

Role: CONTACT

01004385249

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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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.

Reference Type RESULT
PMID: 35359478 (View on PubMed)

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.

Reference Type RESULT
PMID: 35320968 (View on PubMed)

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.

Reference Type RESULT
PMID: 24627001 (View on PubMed)

Other Identifiers

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Soh-Med--25-4-08MS

Identifier Type: -

Identifier Source: org_study_id

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