Nose DiseasesNCT07056582
Pre-emptive Analgesia Using Nebulized Ketamine Versus Nebulized Dexmedetomidine in Endoscopic Nasal Surgeries
A study testing Dexmedetomidine, Ketamine and 0.9%sodium chloride in people with Nose Diseases, run by Sohag University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Nose Diseases
- What is being tested?
- Dexmedetomidine, Ketamine and 0.9%sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients between the ages of 20 and 60,
- both sexes,
- American Society of Anesthesiologists physical status I to II
- BMI ≥18≤30 kg/m²
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hala M Hashem, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
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
- Being tested
- Dexmedetomidine, Ketamine, 0.9%sodium chloride
- Medical subject headings
- Nose Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
patients in this group will receive nebulized Dexmedetomidine before onset of surgery
KetamineDrug
patients in this group will receive nebulized ketamine before onset of surgery
0.9%sodium chlorideDrug
patients in this group will receive nebulized 0.9% normal saline before onset of surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: 0.9%sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start14 Apr 2025
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nose DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Thabet Abdelhameed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056582
- Sponsor's protocol ID
- Soh-Med--25-4-08MS
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35359478Prasant 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.
PubMed 35320968Cai 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.
PubMed 24627001
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Analgesia Using Nebulized Ketamine Versus Nebulized Dexmedetomidine in Endoscopic Nasal Surgeries
- ClinicalTrials.gov ID
- NCT07056582
- Acronym / sponsor ID
- Soh-Med--25-4-08MS
- Conditions
- Nose Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study aims to compare the efficacy of pre-emptive nebulized ketamine versus nebulized dexmedetomidine for post operative pain relief in endoscopic nasal surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group D : will receive dexmedetomidine | Active comparator | Drug: DexmedetomidinePatients 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 K : will receive ketamine | Active comparator | Drug: Ketaminepatients 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 C: will receive .9% saline | Placebo comparator | Drug: 0.9%sodium chloridePatients will receive nebulized normal saline 0.9% (3 ml) 15 minutes prior to the onset of surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients between the ages of 20 and 60,
- both sexes,
- American Society of Anesthesiologists physical status I to II
- BMI ≥18≤30 kg/m²
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidinepatients in this group will receive nebulized Dexmedetomidine before onset of surgery | Drug | group D : will receive dexmedetomidine |
| Ketaminepatients in this group will receive nebulized ketamine before onset of surgery | Drug | group K : will receive ketamine |
| 0.9%sodium chloridepatients in this group will receive nebulized 0.9% normal saline before onset of surgery | Drug | group C: will receive .9% saline |
Primary outcome
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.
Time frame: 24 hours after operation
post operative pain management by VAS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Results publication: PubMed 35359478Parthasarathy 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.
- Results publication: PubMed 35320968Prasant 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.
- Results publication: PubMed 24627001Cai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hala M Hashem, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Ketamine and 0.9%sodium chloride in people with Nose Diseases, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed T Abdelhameed, Resident (01012833899, ahmedthanocloser460@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07056582, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.