Microlaryngeal SurgeryNCT07048873
Dexmedetomidine Versus Ketamine on Laryngeal Microsurgery
A study testing Dexmedetomidine and Ketamine in people with Microlaryngeal Surgery, run by Cairo University at 1 site in Egypt.
Trial summary
compare effect of IV dexmedetomidine and ketamine on pain score, perioperative hemodynamics and detect side effects of dexmedetomidine and ketamine. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Microlaryngeal Surgery
- What is being tested?
- Dexmedetomidine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-70 years ASA I,II
Who cannot join
- CVdiseases as IHD and severe valvular disease.
- allergy to ketamine or dexmedetomidine.
- Patients refusal
- Suspected difficult intubation more than 2 trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine Versus Ketamine on Patients of Laryngeal Microsurgery: a Randomized Controlled Study
compare effect of IV dexmedetomidine and ketamine on pain score, perioperative hemodynamics and detect side effects of dexmedetomidine and ketamine.
Read the detailed description
Microlaryngeal surgery is a common surgical procedure now a days which is associated with many complications such as postoperative pain, airway edema and persistent cough
. the study is to compare the effect of IV dexmedetomidine and ketamine on pain score, perioperative hemodynamics and to detect side effects of dexmedetomidine and ketamine.
- Conditions
- Microlaryngeal Surgery
- Being tested
- Dexmedetomidine, Ketamine, Saline (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
IV dexmedetomidine
KetamineDrug
IV ketamine
Saline (control group)Drug
Also called NO drugs
no drugs
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 1.0mcg/kg of dexmedetomidineloading dose before induction then 0.5 mcg/kg/hr of infused till end of surgery Receives: Drug: Dexmedetomidine |
| Ketamine | Experimental | 0.25 mg/kg/hr ketamine infused till end of surgery Receives: Drug: Ketamine |
| Control | Active comparator | saline before induction infusion till end of surgery Receives: Drug: Saline (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative sore throat
incidence of postoperative sore throat
Measured: 30 minutes postoperative
Secondary outcomes (6)
Ramsey sedation score
Ramsey sedation score RSS (1 to 6)
Measured: 1hour postoperative
postoperative cough incidence
postoperative cough incidence
Measured: 1hour postoperative
incidence of complications
incidence of complications
Measured: 1hour postoperative
Heart Rate
Heart Rate
Measured: 1hour postoperative
Mean Arterial Pressure
Mean Arterial Pressure
Measured: 1hour postoperative
oxygen saturation
oxygen saturation
Measured: 1hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start10 Jan 2024
- Primary completion20 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microlaryngeal SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048873
- Sponsor's protocol ID
- MS-502-2023
- Status last verified
- Jun 2025
- First submitted
- 5 May 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Versus Ketamine on Patients of Laryngeal Microsurgery: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07048873
- Acronym / sponsor ID
- MS-502-2023
- Conditions
- Microlaryngeal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 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.
compare effect of IV dexmedetomidine and ketamine on pain score, perioperative hemodynamics and detect side effects of dexmedetomidine and ketamine.
Detailed description
Microlaryngeal surgery is a common surgical procedure now a days which is associated with many complications such as postoperative pain, airway edema and persistent cough
. the study is to compare the effect of IV dexmedetomidine and ketamine on pain score, perioperative hemodynamics and to detect side effects of dexmedetomidine and ketamine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine1.0mcg/kg of dexmedetomidineloading dose before induction then 0.5 mcg/kg/hr of infused till end of surgery |
| Ketamine | Experimental | Drug: Ketamine0.25 mg/kg/hr ketamine infused till end of surgery |
| Control | Active comparator | Drug: Saline (control group)saline before induction infusion till end of surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18-70 years ASA I,II
Key exclusion criteria (4 listed)
- CVdiseases as IHD and severe valvular disease.
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 |
|---|---|---|
| DexmedetomidineIV dexmedetomidine | Drug | Dexmedetomidine |
| KetamineIV ketamine | Drug | Ketamine |
| Saline (control group)Also: NO drugsno drugs | Drug | Control |
Primary outcome
incidence of postoperative sore throat
Time frame: 30 minutes postoperative
incidence of postoperative sore throat
6 secondary outcomes
Ramsey sedation score
Time frame: 1hour postoperative
postoperative cough incidence
Time frame: 1hour postoperative
incidence of complications
Time frame: 1hour postoperative
Heart Rate
Time frame: 1hour postoperative
Mean Arterial Pressure
Time frame: 1hour postoperative
oxygen saturation
Time frame: 1hour postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Microlaryngeal Surgery
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ketamine in people with Microlaryngeal Surgery, run by Cairo 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 3 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative sore throat (time frame: 30 minutes postoperative). 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 3 Jul 2025.