Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMYNCT06981494
Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries
A study testing Dexmedetomidine and Dexmedetomidine and ketamine ( Ketodex ) in people with Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY, run by Sohag University at 1 site in Egypt.
Trial summary
The study aims to compare the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries. Assessment the analgesic and sedative role of both drugs. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY
- What is being tested?
- Dexmedetomidine and Dexmedetomidine and ketamine ( Ketodex )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2025to 10 Dec 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age Range: Patients aged 18-60 years who are scheduled for elective Ear and nose surgeries requiring controlled hypotensive anesthesia.
- ASA Classification: Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Surgical Procedures: Individuals undergoing specific ear and nose surgeries where controlled hypotensive anesthesia is typically indicated.
- Stable Cardiovascular Health: Patients with stable cardiovascular function, without significant history of uncontrolled hypertension , hypotension or ischaemic heart diseases.
Who cannot join
- Severe Cardiovascular Conditions: Patients with severe cardiovascular diseases such as congestive heart failure, uncontrolled hypertension , arrhythmias or ischaemic heart diseases .
- Any cardiac patients.
- Respiratory Conditions: Individuals with significant respiratory conditions like chronic obstructive pulmonary disease (COPD) or severe asthma.
- Drug Allergies: Patients with known hypersensitivity or allergic reactions to dexmedetomidine, ketamine or any other components of the study drugs.
- Pregnancy or Lactation: Pregnant or breastfeeding women, due to potential risks to the fetus or infant.
- Chronic Medication Use: Patients on chronic medications that could interfere with blood pressure regulation or interact with the study drugs (e.g., beta-blockers, MAO inhibitors).
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- Patients with chronic liver or renal diseases.
- Psychiatric or Neurological Disorders: Individuals with severe psychiatric or neurological disorders that could impact the study outcomes or the patient's ability to consent.
- Substance Abuse: Patients with a history of substance abuse, particularly involving sedatives or opioids, which could affect anesthesia requirements or recovery.
- Coagulation Disorders: Individuals with coagulation disorders or on anticoagulant therapy, due to the increased risk of bleeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Sohag
Magdy M Amin, 0934602963, Portal@med.sohag.edu.eg
About this study
Official title: Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) Regarding Hemodynamics Stability, Recovery and Postoperative Pain in Ear and Nose Surgeries, A Prospective Randomized Study
The study aims to compare the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries.
- Assessment the analgesic and sedative role of both drugs.
Read the detailed description
Comparison regarding the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries.
- comparison between both drugs in recovery and hemodynamics stability
- Assessment the analgesic and sedative role of both drugs
- Being tested
- Dexmedetomidine, Dexmedetomidine and ketamine ( Ketodex )
- Medical subject headings
- Microphthalmia, syndromic 7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Loading Dose:
Dexmedetomidine is usually administered as a loading dose of 0.25 mcg/kg slowly.
Maintenance Dose:
After the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response.
Dexmedetomidine and ketamine ( Ketodex )Drug
Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):
Ketamine Component:
Loading Dose:
Ketamine is typically given at a dose of 0.5 mg/kg as a bolus injection.
Maintenance Dose:
A maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump.
Dexmedetomidine Component:
Loading Dose:
As with the dexmedetomidine group, a loading dose of 0.25 mcg/kg slowly is administered.
Maintenance Dose:
The maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group (D) | Active comparator | Dexmedetomidine Group (D) :
We give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine
Loading Dose:
Dexmedetomidine is usually administered as a loading dose of 0.5 mcg/kg slowly.
Maintenance Dose:
After the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response. Receives: Drug: Dexmedetomidine |
| Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K): | Active comparator | Ketamine Component:
We give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine and ketamine
Loading Dose:
Ketamine is typically given at a dose of 0.5 mg/kg as a bolus injection.
Maintenance Dose:
A maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump.
Dexmedetomidine Component:
Loading Dose:
As with the dexmedetomidine group, a loading dose of 0.5 mcg/kg slowly is administered.
Maintenance Dose:
The maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump. Receives: Drug: Dexmedetomidine and ketamine ( Ketodex ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hemodynmaic stability
Assess Hemodynamic Stability: Compare the hemodynamic stability provided by dexmedetomidine and ketodex, focusing on parameters such as blood pressure and heart rate will be monitored every 5 minutes and we will record the average every 20 minutes intraoperative . This monitoring will help assess the stability of each patient and the safety profile of the anesthetic agents used in the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start5 Feb 2025
- Primary completion10 Aug 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMYStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madonna Samir Sobhy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981494
- Sponsor's protocol ID
- Soh-Med--25-4-02MS
- Status last verified
- May 2025
- First submitted
- 26 Dec 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) Regarding Hemodynamics Stability, Recovery and Postoperative Pain in Ear and Nose Surgeries, A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06981494
- Acronym / sponsor ID
- Soh-Med--25-4-02MS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 20 May 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.
The study aims to compare the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries.
- Assessment the analgesic and sedative role of both drugs.
Detailed description
Comparison regarding the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries.
- comparison between both drugs in recovery and hemodynamics stability
- Assessment the analgesic and sedative role of both drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group (D) | Active comparator | Drug: DexmedetomidineDexmedetomidine Group (D) : We give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine Loading Dose: Dexmedetomidine is usually administered as a loading dose of 0.5 mcg/kg slowly. Maintenance Dose: After the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response. |
| Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K): | Active comparator | Drug: Dexmedetomidine and ketamine ( Ketodex )Ketamine Component: We give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine and ketamine Loading Dose: Ketamine is typically given at a dose of 0.5 mg/kg as a bolus injection. Maintenance Dose: A maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump. Dexmedetomidine Component: Loading Dose: As with the dexmedetomidine group, a loading dose of 0.5 mcg/kg slowly is administered. Maintenance Dose: The maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age Range: Patients aged 18-60 years who are scheduled for elective Ear and nose surgeries requiring controlled hypotensive anesthesia.
- ASA Classification: Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Surgical Procedures: Individuals undergoing specific ear and nose surgeries where controlled hypotensive anesthesia is typically indicated.
- Stable Cardiovascular Health: Patients with stable cardiovascular function, without significant history of uncontrolled hypertension , hypotension or ischaemic heart diseases.
Key exclusion criteria (10 listed)
- Severe Cardiovascular Conditions: Patients with severe cardiovascular diseases such as congestive heart failure, uncontrolled hypertension , arrhythmias or ischaemic heart diseases .
- Any cardiac patients.
- Respiratory Conditions: Individuals with significant respiratory conditions like chronic obstructive pulmonary disease (COPD) or severe asthma.
- Drug Allergies: Patients with known hypersensitivity or allergic reactions to dexmedetomidine, ketamine or any other components of the study drugs.
- Pregnancy or Lactation: Pregnant or breastfeeding women, due to potential risks to the fetus or infant.
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 |
|---|---|---|
| DexmedetomidineLoading Dose: Dexmedetomidine is usually administered as a loading dose of 0.25 mcg/kg slowly. Maintenance Dose: After the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response. | Drug | Dexmedetomidine Group (D) |
| Dexmedetomidine and ketamine ( Ketodex )Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K): Ketamine Component: Loading Dose: Ketamine is typically given at a dose of 0.5 mg/kg as a bolus injection. Maintenance Dose: A maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump. Dexmedetomidine Component: Loading Dose: As with the dexmedetomidine group, a loading dose of 0.25 mcg/kg slowly is administered. Maintenance Dose: The maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump. | Drug | Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K): |
Primary outcome
Assessment of hemodynmaic stability
Time frame: 6 months
Assess Hemodynamic Stability: Compare the hemodynamic stability provided by dexmedetomidine and ketodex, focusing on parameters such as blood pressure and heart rate will be monitored every 5 minutes and we will record the average every 20 minutes intraoperative . This monitoring will help assess the stability of each patient and the safety profile of the anesthetic agents used in the study.
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 20 May 2025.
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.
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 and Dexmedetomidine and ketamine ( Ketodex ) in people with Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY, 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 10 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 20 May 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of hemodynmaic stability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.