VaricocelectomyPhase 4NCT07214701
Sedative and Analgesic Effects of Dexmedetomidine Versus Ketamine in Patients Undergoing Varicocelectomy Under Spinal Anaesthesia: A Prospective Randomized Comparative Trial
A Phase 4 study testing Ketamine (0.5 mg/kg) and Dexmedetomidine in people with Varicocelectomy, run by Assiut University.
Trial summary
The demand for safe and effective sedation during spinal anesthesia has increased in recent years, particularly in ambulatory and minor surgical procedures. The ideal sedative agent should provide adequate anxiolysis and comfort, maintain cardiorespiratory stability, and allow rapid recovery without significant… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Varicocelectomy
- What is being tested?
- Ketamine (0.5 mg/kg) and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Dec 2026
- Phase
- Phase 4
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: from 18 to 40 years
- Sex: Male patients
- Operation: varicocelectomy under spinal anesthesia
- ASA physical states I-II
Who cannot join
- Psychiatric or neurological disorders
- Respiratory disorders
- Cardiovascular disorders
- Coagulation disorders
- Contraindications to neuraxial block (allergy to L.A, peripheral issues)
- spine deformity
About this study
The demand for safe and effective sedation during spinal anesthesia has increased in recent years, particularly in ambulatory and minor surgical procedures. The ideal sedative agent should provide adequate anxiolysis and comfort, maintain cardiorespiratory stability, and allow rapid recovery without significant adverse effects .
Ketamine, a phencyclidine derivative, produces sedation, analgesia, and amnesia while maintaining airway reflexes and spontaneous respiration. However, it is often associated with undesirable psychomimetic reactions and sympathetic stimulation, including tachycardia and hypertension .
Read more
In contrast, dexmedetomidine, a highly selective α2-adrenergic agonist, provides cooperative sedation, analgesia, and reduced anesthetic requirements, but it may cause bradycardia and hypotension, particularly at higher doses .
The combination of ketamine and dexmedetomidine (often referred to as "Ketadex") has recently gained attention due to its synergistic effects. Evidence suggests that this combination improves hemodynamic stability, decreases emergence agitation, and provides superior analgesia compared to either agent alone [4,5]. Moreover, ketamine counteracts the bradycardia and hypotension induced by dexmedetomidine, while dexmedetomidine mitigates ketamine-induced psychomimetic side effects .
Despite these advantages, the optimal dosing regimen and comparative efficacy of the two drugs when used individually remain subjects of clinical debate. Recent randomized controlled trials comparing intravenous dexmedetomidine and ketamine during spinal anesthesia reported differences in sedation quality, hemodynamic stability, and recovery profile . Therefore, this study aims to compare the sedative and hemodynamic effects of intravenous dexmedetomidine versus ketamine infusion in patients undergoing varicocelectomy under spinal anesthesia.
the study aim to Compare sedative, analgesic efficacy, and safety profile of intravenous dexmedetomidine versus ketamine in patients undergoing varicocelectomy under spinal anaesthesia
- Conditions
- Varicocelectomy
- Being tested
- Ketamine (0.5 mg/kg), Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (0.5 mg/kg)Drug
Intravenous infusion of ketamine 0.5 mg/kg over 10 minutes before spinal injection, diluted in 50 ml 0.9% NaCl Saline
DexmedetomidineDrug
Intravenous infusion of dexmedetomidine 0.25 μg/kg over 10 minutes before spinal injection, diluted in 50 ml 0.9% NaCl Saline
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patiets received Dexmedetomidine Receives: Drug: Dexmedetomidine |
| Group B | Active comparator | patients receive Ketamine Receives: Drug: Ketamine (0.5 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time required in minutes to achieve OAA/S score 4.
Modified observer's assessment of alertness/sedation score (OAA/S):
5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking
1 Responds only after painful stimulus 0 No response even after painful stimulus
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricocelectomyStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed khalifa Mahmoud Saleh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214701
- Sponsor's protocol ID
- dexmedet VS ketamine
- Status last verified
- Oct 2025
- First submitted
- 5 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedative and Analgesic Effects of Dexmedetomidine Versus Ketamine in Patients Undergoing Varicocelectomy Under Spinal Anaesthesia: A Prospective Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT07214701
- Acronym / sponsor ID
- dexmedet VS ketamine
- Conditions
- Varicocelectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Oct 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 demand for safe and effective sedation during spinal anesthesia has increased in recent years, particularly in ambulatory and minor surgical procedures. The ideal sedative agent should provide adequate anxiolysis and comfort, maintain cardiorespiratory stability, and allow rapid recovery without significant adverse effects .
Ketamine, a phencyclidine derivative, produces sedation, analgesia, and amnesia while maintaining airway reflexes and spontaneous respiration. However, it is often associated with undesirable psychomimetic reactions and sympathetic stimulation, including tachycardia and hypertension .
In contrast, dexmedetomidine, a highly selective α2-adrenergic agonist, provides cooperative sedation, analgesia, and reduced anesthetic requirements, but it may cause bradycardia and hypotension, particularly at higher doses .
The combination of ketamine and dexmedetomidine (often referred to as "Ketadex") has recently gained attention due to its synergistic effects. Evidence suggests that this combination improves hemodynamic stability, decreases emergence agitation, and provides superior analgesia compared to either agent alone [4,5]. Moreover, ketamine counteracts the bradycardia and hypotension induced by dexmedetomidine, while dexmedetomidine mitigates ketamine-induced psychomimetic side effects .
Despite these advantages, the optimal dosing regimen and comparative efficacy of the two drugs when used individually remain subjects of clinical debate. Recent randomized controlled trials comparing intravenous dexmedetomidine and ketamine during spinal anesthesia reported differences in sedation quality, hemodynamic stability, and recovery profile . Therefore, this study aims to compare the sedative and hemodynamic effects of intravenous dexmedetomidine versus ketamine infusion in patients undergoing varicocelectomy under spinal anesthesia.
the study aim to Compare sedative, analgesic efficacy, and safety profile of intravenous dexmedetomidine versus ketamine in patients undergoing varicocelectomy under spinal anaesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexmedetomidinepatiets received Dexmedetomidine |
| Group B | Active comparator | Drug: Ketamine (0.5 mg/kg)patients receive Ketamine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: from 18 to 40 years
- Sex: Male patients
- Operation: varicocelectomy under spinal anesthesia
- ASA physical states I-II
Key exclusion criteria (6 listed)
- Psychiatric or neurological disorders
- Respiratory disorders
- Cardiovascular disorders
- Coagulation disorders
- Contraindications to neuraxial block (allergy to L.A, peripheral issues)
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 |
|---|---|---|
| Ketamine (0.5 mg/kg)Intravenous infusion of ketamine 0.5 mg/kg over 10 minutes before spinal injection, diluted in 50 ml 0.9% NaCl Saline | Drug | Group B |
| DexmedetomidineIntravenous infusion of dexmedetomidine 0.25 μg/kg over 10 minutes before spinal injection, diluted in 50 ml 0.9% NaCl Saline | Drug | Group A |
Primary outcome
the time required in minutes to achieve OAA/S score 4.
Time frame: 24 hour
Modified observer's assessment of alertness/sedation score (OAA/S): 5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking 1 Responds only after painful stimulus 0 No response even after painful stimulus
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 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine (0.5 mg/kg) and Dexmedetomidine in people with Varicocelectomy, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
the time required in minutes to achieve OAA/S score 4. (time frame: 24 hour). 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 9 Oct 2025.