Tourniquet HypertensionPhase 2torniquetNCT06936410
Using Lidocaine or Dexmedetomidine to Help Control Blood Pressure Spikes From a Tourniquet During Knee Surgery
A Phase 2 study testing Lidocaine 2% Injectable Solution and Dexmedetomidine HCL Injection in people with Tourniquet Hypertension, run by Cairo University at 1 site in Egypt.
Trial summary
Knee pain is very common, and more people are having minor knee surgeries done through a small camera (arthroscopy), often as outpatients. During these surgeries, a device called a tourniquet is used to reduce bleeding by stopping blood flow to the leg. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tourniquet Hypertension
- What is being tested?
- Lidocaine 2% Injectable Solution and Dexmedetomidine HCL Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 14 Mar 2026
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients (males and females) of ASA class I or II, age from 18-60 years old, undergoing ambulatory knee arthroscopy under general anaesthesia using tourniquet.
Who cannot join
- Patients with uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, and chronic obstructive lung disease),
- Patients with significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
- Patients with morbid obesity (BMI >35).
- Patients with a history of allergy to the drugs used in this study.
- Patients who have history of chronic use of opioids.
- Cases with tourniquet times of less than 60 minutes or longer than 150 minutes were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Infusion of Lidocaine vs. Dexmedetomidine for Decreasing Tourniquet Induced Hypertension (TIH) in Ambulatory Arthroscopic Knee Surgeries Under General Anesthesia
Knee pain is very common, and more people are having minor knee surgeries done through a small camera (arthroscopy), often as outpatients. During these surgeries, a device called a tourniquet is used to reduce bleeding by stopping blood flow to the leg. However, this can sometimes cause a sharp rise in blood pressure-a condition known as tourniquet-induced hypertension (TIH), which happens in about 67% of patients under general anesthesia.
this study looked at two different drugs-Dexmedetomidine and Lidocaine- to see which one works better in preventing this blood pressure rise during surgery.
Read more
Dexmedetomidine is a medicine that calms the nervous system and helps lower blood pressure and pain, but it can sometimes cause side effects like a slow heart rate and low blood pressure. Lidocaine, commonly used to numb pain, also helps with inflammation and controlling pain sensitivity.
In this study, both drugs helped reduce TIH, but Dexmedetomidine was more effective. However, it came with more side effects compared to Lidocaine.
Read the detailed description
Knee pain is very common and ambulatory knee arthroscopic surgery has increased significantly. Clinical studies comparing spinal anaesthesia to general anaesthesia (GA), have found that GA resulted in slightly shorter hospital stay, earlier mobilization, and fewer cases of urinary retention; that is why the investigators preferred in this study to choose the general anaesthesia over spinal anaesthesia in patients undergoing ambulatory knee arthroscopic surgeries.
Tourniquet induced hypertension defined as an increase of at least 30% in the systolic blood pressure or diastolic blood pressure within one hour of the tourniquet inflation, which may affect the response to analgesia and the need for antihypertensive drug. The incidence of TIH in patients undergoing general anaesthesia using tourniquet is 67%.
Previous studies were conducted to investigate the effect of different drugs such as Lidocaine, Ketamine or Dexmedetomidine in managing TIH.
This study used Dexmedetomidine to decrease the TIH, and another one, used Lidocaine as bolus plus infusion to decrease the TIH, but to our knowledge no study was done to compare between both drugs in decreasing TIH. Dexmedetomidine is a selective, short acting agonist of the alpha 2 receptors, it has a sympatholytic effect, in addition to antihypertensive, anxiolytic, sedative and analgesic effects.
Lidocaine is an anti-inflammatory drug with an analgesic and anti-hyperalgesia effect. It is also used in attenuating the stress response that can occur while using the laryngoscope.
This study aimed to compare the effect of IV infusion of dexmedetomidine with the effect of IV Lidocaine in decreasing the TIH in patients undergoing ambulatory arthroscopic knee surgeries using the tourniquet under general anaesthesia.
This randomized, comparative and double blinded study on 180 patients undergoing ambulatory knee arthroscopy under general anaesthesia using tourniquet. Patients were randomly allocated into two equal groups: Lidocaine group (group L): patients received lidocaine 2%, 1 mg/kg and dexmedetomidine group (group D): patients received a loading dose of (0.8 μg·kg-1 over 10 min) followed by continuous infusion of (0.4 μg·kg-1.h-1) diluted in 50 ml of normal saline.
- Conditions
- Tourniquet Hypertension
- Being tested
- Lidocaine 2% Injectable Solution, Dexmedetomidine HCL Injection
- Keywords
- lidocaine, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% Injectable SolutionDrug
patients received Lidocaine 2%, 1 mg/kg, IV bolus over 10 mins after the induction of anaesthesia , followed by Lidocaine infusion (2 mg/kg/h) diluted in 50 ml of normal saline with a maximum dose of 200 mg/h. The tourniquet was inflated 10 minutes after the start of the Lidocaine infusion then the Lidocaine infusion stopped at the time of tourniquet deflation
Dexmedetomidine HCL InjectionDrug
patients received a loading dose of Dexmedetomidine-Pfizer (0.8 μg·kg-1 over 10 min) followed by continuous infusion of Dexmedetomidine (0.4 μg·kg-1.h-1) diluted in 50 ml of normal saline. The tourniquet was inflated 10 mins after the start of Dexmedetomidine infusion then the Dexmedetomidine infusion stopped at the time of the tourniquet deflation.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine group (group L) | Active comparator | patients received Lidocaine 2%, 1 mg/kg, IV bolus over 10 mins after the induction of anaesthesia , followed by Lidocaine infusion (2 mg/kg/h) diluted in 50 ml of normal saline with a maximum dose of 200 mg/h. The tourniquet was inflated 10 minutes after the start of the Lidocaine infusion then the Lidocaine infusion stopped at the time of tourniquet deflation Receives: Drug: Dexmedetomidine HCL Injection |
| dexmedetomidine group (group D) | Active comparator | atients received a loading dose of Dexmedetomidine-Pfizer (0.8 μg·kg-1 over 10 min) followed by continuous infusion of Dexmedetomidine (0.4 μg·kg-1.h-1) diluted in 50 ml of normal saline. The tourniquet was inflated 10 mins after the start of Dexmedetomidine infusion then the Dexmedetomidine infusion stopped at the time of the tourniquet deflation. Receives: Drug: Lidocaine 2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of tourniquet induced hypertension
which is defined as increase in the SBP 30% from the baseline reading in both groups, at 60 mins after tourniquet inflation
Measured: from 60 minutes after tourniquet inflation till end of surgery
Secondary outcomes (1)
Hemodynamic measurements: SBP, DBP, MAP and HR.
Measured: from baseline till 1 hour after end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Mar 2025
- Primary completion14 Mar 2026
- Study completion14 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourniquet HypertensionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa mahmoud bahaa eldin mohamed taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936410
- Sponsor's protocol ID
- Ms-532-2023
- Acronym
- torniquet
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Infusion of Lidocaine vs. Dexmedetomidine for Decreasing Tourniquet Induced Hypertension (TIH) in Ambulatory Arthroscopic Knee Surgeries Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06936410
- Acronym / sponsor ID
- torniquet / Ms-532-2023
- Conditions
- Tourniquet Hypertension
- Keywords
- lidocaine, dexmedetomidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 14 Mar 2026 (actual)
- First posted
- 20 Apr 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.
Knee pain is very common, and more people are having minor knee surgeries done through a small camera (arthroscopy), often as outpatients. During these surgeries, a device called a tourniquet is used to reduce bleeding by stopping blood flow to the leg. However, this can sometimes cause a sharp rise in blood pressure-a condition known as tourniquet-induced hypertension (TIH), which happens in about 67% of patients under general anesthesia.
this study looked at two different drugs-Dexmedetomidine and Lidocaine- to see which one works better in preventing this blood pressure rise during surgery.
Dexmedetomidine is a medicine that calms the nervous system and helps lower blood pressure and pain, but it can sometimes cause side effects like a slow heart rate and low blood pressure. Lidocaine, commonly used to numb pain, also helps with inflammation and controlling pain sensitivity.
In this study, both drugs helped reduce TIH, but Dexmedetomidine was more effective. However, it came with more side effects compared to Lidocaine.
Detailed description
Knee pain is very common and ambulatory knee arthroscopic surgery has increased significantly. Clinical studies comparing spinal anaesthesia to general anaesthesia (GA), have found that GA resulted in slightly shorter hospital stay, earlier mobilization, and fewer cases of urinary retention; that is why the investigators preferred in this study to choose the general anaesthesia over spinal anaesthesia in patients undergoing ambulatory knee arthroscopic surgeries.
Tourniquet induced hypertension defined as an increase of at least 30% in the systolic blood pressure or diastolic blood pressure within one hour of the tourniquet inflation, which may affect the response to analgesia and the need for antihypertensive drug. The incidence of TIH in patients undergoing general anaesthesia using tourniquet is 67%.
Previous studies were conducted to investigate the effect of different drugs such as Lidocaine, Ketamine or Dexmedetomidine in managing TIH.
This study used Dexmedetomidine to decrease the TIH, and another one, used Lidocaine as bolus plus infusion to decrease the TIH, but to our knowledge no study was done to compare between both drugs in decreasing TIH. Dexmedetomidine is a selective, short acting agonist of the alpha 2 receptors, it has a sympatholytic effect, in addition to antihypertensive, anxiolytic, sedative and analgesic effects.
Lidocaine is an anti-inflammatory drug with an analgesic and anti-hyperalgesia effect. It is also used in attenuating the stress response that can occur while using the laryngoscope.
This study aimed to compare the effect of IV infusion of dexmedetomidine with the effect of IV Lidocaine in decreasing the TIH in patients undergoing ambulatory arthroscopic knee surgeries using the tourniquet under general anaesthesia.
This randomized, comparative and double blinded study on 180 patients undergoing ambulatory knee arthroscopy under general anaesthesia using tourniquet. Patients were randomly allocated into two equal groups: Lidocaine group (group L): patients received lidocaine 2%, 1 mg/kg and dexmedetomidine group (group D): patients received a loading dose of (0.8 μg·kg-1 over 10 min) followed by continuous infusion of (0.4 μg·kg-1.h-1) diluted in 50 ml of normal saline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine group (group L) | Active comparator | Drug: Dexmedetomidine HCL Injectionpatients received Lidocaine 2%, 1 mg/kg, IV bolus over 10 mins after the induction of anaesthesia , followed by Lidocaine infusion (2 mg/kg/h) diluted in 50 ml of normal saline with a maximum dose of 200 mg/h. The tourniquet was inflated 10 minutes after the start of the Lidocaine infusion then the Lidocaine infusion stopped at the time of tourniquet deflation |
| dexmedetomidine group (group D) | Active comparator | Drug: Lidocaine 2% Injectable Solutionatients received a loading dose of Dexmedetomidine-Pfizer (0.8 μg·kg-1 over 10 min) followed by continuous infusion of Dexmedetomidine (0.4 μg·kg-1.h-1) diluted in 50 ml of normal saline. The tourniquet was inflated 10 mins after the start of Dexmedetomidine infusion then the Dexmedetomidine infusion stopped at the time of the tourniquet deflation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients (males and females) of ASA class I or II, age from 18-60 years old, undergoing ambulatory knee arthroscopy under general anaesthesia using tourniquet.
Key exclusion criteria (6 listed)
- Patients with uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, and chronic obstructive lung disease),
- Patients with significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
- Patients with morbid obesity (BMI >35).
- Patients with a history of allergy to the drugs used in this study.
- Patients who have history of chronic use of opioids.
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 |
|---|---|---|
| Lidocaine 2% Injectable Solutionpatients received Lidocaine 2%, 1 mg/kg, IV bolus over 10 mins after the induction of anaesthesia , followed by Lidocaine infusion (2 mg/kg/h) diluted in 50 ml of normal saline with a maximum dose of 200 mg/h. The tourniquet was inflated 10 minutes after the start of the Lidocaine infusion then the Lidocaine infusion stopped at the time of tourniquet deflation | Drug | dexmedetomidine group (group D) |
| Dexmedetomidine HCL Injectionpatients received a loading dose of Dexmedetomidine-Pfizer (0.8 μg·kg-1 over 10 min) followed by continuous infusion of Dexmedetomidine (0.4 μg·kg-1.h-1) diluted in 50 ml of normal saline. The tourniquet was inflated 10 mins after the start of Dexmedetomidine infusion then the Dexmedetomidine infusion stopped at the time of the tourniquet deflation. | Drug | lidocaine group (group L) |
Primary outcome
Incidence of tourniquet induced hypertension
Time frame: from 60 minutes after tourniquet inflation till end of surgery
which is defined as increase in the SBP 30% from the baseline reading in both groups, at 60 mins after tourniquet inflation
1 secondary outcome
Hemodynamic measurements: SBP, DBP, MAP and HR.
Time frame: from baseline till 1 hour after end of operation
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 17 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for Tourniquet Hypertension
Recruiting
Gradual Versus Intermittent Release of Tourniquet Effect on MAP in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries
Hemodynamics
Recruiting
A Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery
Tourniquet Hypertension
RecruitingPhase 4
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Tourniquet Hypertension, Intraoperative Hypertension
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 Phase 2 study testing Lidocaine 2% Injectable Solution and Dexmedetomidine HCL Injection in people with Tourniquet Hypertension, 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 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: finished, as of the sponsor's last update on 17 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 tourniquet induced hypertension (time frame: from 60 minutes after tourniquet inflation till end of surgery). 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 17 Mar 2026.