Intrathecal DexmedetomidineNCT07522736
Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery
A study testing Dexmedetomidine 4 μg, Dexmedetomidine 8 μg and Dexmedetomidine 12 μg in people with Intrathecal Dexmedetomidine and Bupivacaine, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the duration of analgesia (as the primary outcome) and adverse effects (as the secondary outcome) after intrathecal administration of dexmedetomidine with hyperbaric bupivacaine to patients undergoing knee orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intrathecal Dexmedetomidine, Bupivacaine, Knee Orthopedic Surgery
- What is being tested?
- Dexmedetomidine 4 μg, Dexmedetomidine 8 μg and Dexmedetomidine 12 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 30 Aug 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Male patients scheduled for knee orthopedic surgery.
Who cannot join
- Patients with psychiatric disorders.
- History of drug addiction.
- Contraindication for regional anesthesia.
- History of hypersensitivity to the study drugs.
- Previous administration of opioids and/or other central nervous system depressants during current hospital admission.
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
Cairo University
Cairo, 12613
Ahmed A Ismail, MSc, 00201115746779, ahmed.ali39348@postgrad.kasralainy.edu.eg
Osama M Asaad, MD
About this study
Official title: The Analgesic Effect of Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery: A Randomized Double-Blinded Dose-Finding Trial
This study aims to compare the duration of analgesia (as the primary outcome) and adverse effects (as the secondary outcome) after intrathecal administration of dexmedetomidine with hyperbaric bupivacaine to patients undergoing knee orthopedic surgery.
Read the detailed description
Intrathecal adjuncts are commonly added to local anesthetic agents, to improve the duration of nerve blocks and postoperative pain relief without increasing the dosage of local anesthetic.
Studies have shown that dexmedetomidine (DEX) has a greater potential for enhancing analgesic effects due to its higher specificity for alpha2 adrenoceptors. DEX is commonly used for sedation and as an adjunct to reduce the amount of anesthesia and opioids required during general and regional anesthesia in both adults and children.
- Being tested
- Dexmedetomidine 4 μg, Dexmedetomidine 8 μg, Dexmedetomidine 12 μg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 4 μgDrug
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg.
Dexmedetomidine 8 μgDrug
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg.
Dexmedetomidine 12 μgDrug
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg. Receives: Drug: Dexmedetomidine 4 μg |
| Group II | Experimental | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg. Receives: Drug: Dexmedetomidine 8 μg |
| Group III | Experimental | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg. Receives: Drug: Dexmedetomidine 12 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to request rescue analgesia
Time to request rescue analgesia will be recorded from the end of surgery to the first dose of morphine administrated
Measured: 24 hours postoperatively
Secondary outcomes (4)
Heart rate
Heart rate will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.
Measured: In the recovery room (Up to 2 hours)
Mean arterial blood pressure
Mean arterial blood pressure will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.
Measured: In the recovery room (Up to 2 hours)
Respiratory rate
Respiratory rate will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.
Measured: In the recovery room (Up to 2 hours)
Oxygen saturation
Oxygen saturation will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.
Measured: In the recovery room (Up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Mar 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal DexmedetomidineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdou Ali Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522736
- Sponsor's protocol ID
- MD-70-2025
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery: A Randomized Double-Blinded Dose-Finding Trial
- ClinicalTrials.gov ID
- NCT07522736
- Acronym / sponsor ID
- MD-70-2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 13 Apr 2026 (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 duration of analgesia (as the primary outcome) and adverse effects (as the secondary outcome) after intrathecal administration of dexmedetomidine with hyperbaric bupivacaine to patients undergoing knee orthopedic surgery.
Detailed description
Intrathecal adjuncts are commonly added to local anesthetic agents, to improve the duration of nerve blocks and postoperative pain relief without increasing the dosage of local anesthetic.
Studies have shown that dexmedetomidine (DEX) has a greater potential for enhancing analgesic effects due to its higher specificity for alpha2 adrenoceptors. DEX is commonly used for sedation and as an adjunct to reduce the amount of anesthesia and opioids required during general and regional anesthesia in both adults and children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Dexmedetomidine 4 μgPatients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg. |
| Group II | Experimental | Drug: Dexmedetomidine 8 μgPatients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg. |
| Group III | Experimental | Drug: Dexmedetomidine 12 μgPatients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Male patients scheduled for knee orthopedic surgery.
Key exclusion criteria (5 listed)
- Patients with psychiatric disorders.
- History of drug addiction.
- Contraindication for regional anesthesia.
- History of hypersensitivity to the study drugs.
- Previous administration of opioids and/or other central nervous system depressants during current hospital admission.
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 |
|---|---|---|
| Dexmedetomidine 4 μgPatients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg. | Drug | Group I |
| Dexmedetomidine 8 μgPatients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg. | Drug | Group II |
| Dexmedetomidine 12 μgPatients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg. | Drug | Group III |
Primary outcome
Time to request rescue analgesia
Time frame: 24 hours postoperatively
Time to request rescue analgesia will be recorded from the end of surgery to the first dose of morphine administrated
4 secondary outcomes
Heart rate
Time frame: In the recovery room (Up to 2 hours)
Mean arterial blood pressure
Time frame: In the recovery room (Up to 2 hours)
Respiratory rate
Time frame: In the recovery room (Up to 2 hours)
Oxygen saturation
Time frame: In the recovery room (Up to 2 hours)
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 4 μg, Dexmedetomidine 8 μg and Dexmedetomidine 12 μg in people with Intrathecal Dexmedetomidine and Bupivacaine, 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 3 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 13 Apr 2026. 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?
Contact Ahmed A Ismail, MSc (00201115746779, ahmed.ali39348@postgrad.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to request rescue analgesia (time frame: 24 hours postoperatively). 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 13 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.