LidocaineNCT06837519
Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
A study testing Lidocaine, Dexmedetomidine and Lidocaine and Dexmedetomidine in people with Lidocaine and Dexmedetomidine, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lidocaine, Dexmedetomidine, Infusion
- What is being tested?
- Lidocaine, Dexmedetomidine and Lidocaine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 1 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status of I, II.
- Patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.
Who cannot join
- Hypersensitivity to any of the used drugs.
- Coagulation disorder.
- Body mass index >35 kg/m2.
- History of chronic pain requiring daily opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks, and drug/alcohol abuse.
- Contraindication to the use of local anesthetics.
- Cardiovascular disease.
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- Severe respiratory, renal or hepatic impairment.
- Insulin-dependent diabetes mellitus.
- Central nervous system or psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blind Trial Comparing Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
This study aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery.
Read the detailed description
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure allowing the reduction of surgical stress. However, postoperative pain management is crucial for patients undergoing VATS, as inadequate pain control can lead to complications (such as lung atelectasis), prolonged recovery, and decreased patient satisfaction.
Dexmedetomidine has shown positive effects on postoperative pain intensity, opioid consumption and other recovery parameters, such as postoperative nausea and vomiting (PONV), and speed of recovery.
Lidocaine has exhibited an excellent safety profile when administered as a low-dose infusion for cancer or non-cancer chronic pain.
- Conditions
- Lidocaine, Dexmedetomidine, Infusion, Perioperative Pain, Video-Assisted Thoracoscopic Surgery
- Being tested
- Lidocaine, Dexmedetomidine, Lidocaine and Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Patients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine.
DexmedetomidineDrug
Patients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine.
Lidocaine and DexmedetomidineDrug
Patients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | Patients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine Receives: Drug: Lidocaine |
| Dexmedetomidine group | Experimental | Patients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine. Receives: Drug: Dexmedetomidine |
| Lidocaine and Dexmedetomidine group | Experimental | Patients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation. Receives: Drug: Lidocaine and Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)> 3 to be repeated after 30 min if pain persists until the VAS < 4.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Time of extubation
Time from the end of surgery till extubation
Measured: 24 hours postoperatively
Time to the first request for the rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
Measured: 24 hours postoperatively
Degree of patient satisfaction
The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, pruritis, respiratory depression, lidocaine toxicity (such as lightheadedness, somnolence, perioral numbness, dry mouth, metallic taste, dysarthria or fits) or any other complication will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start20 Feb 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LidocaineStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837519
- Sponsor's protocol ID
- FMASU R22/2025
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2025
- Last updated
- 21 Jul 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Trial Comparing Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT06837519
- Acronym / sponsor ID
- FMASU R22/2025
- Conditions
- Lidocaine, Dexmedetomidine, Infusion, Perioperative Pain, Video-Assisted Thoracoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 20 Feb 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.
This study aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery.
Detailed description
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure allowing the reduction of surgical stress. However, postoperative pain management is crucial for patients undergoing VATS, as inadequate pain control can lead to complications (such as lung atelectasis), prolonged recovery, and decreased patient satisfaction.
Dexmedetomidine has shown positive effects on postoperative pain intensity, opioid consumption and other recovery parameters, such as postoperative nausea and vomiting (PONV), and speed of recovery.
Lidocaine has exhibited an excellent safety profile when administered as a low-dose infusion for cancer or non-cancer chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: LidocainePatients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine. |
| Lidocaine and Dexmedetomidine group | Experimental | Drug: Lidocaine and DexmedetomidinePatients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status of I, II.
- Patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.
Key exclusion criteria (9 listed)
- Hypersensitivity to any of the used drugs.
- Coagulation disorder.
- Body mass index >35 kg/m2.
- History of chronic pain requiring daily opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks, and drug/alcohol abuse.
- Contraindication to the use of local anesthetics.
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 |
|---|---|---|
| LidocainePatients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine. | Drug | Lidocaine group |
| DexmedetomidinePatients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine. | Drug | Dexmedetomidine group |
| Lidocaine and DexmedetomidinePatients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation. | Drug | Lidocaine and Dexmedetomidine group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)> 3 to be repeated after 30 min if pain persists until the VAS < 4.
5 secondary outcomes
Time of extubation
Time frame: 24 hours postoperatively
Time to the first request for the rescue analgesia
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
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 21 Jul 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. 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 Lidocaine, Dexmedetomidine and Lidocaine and Dexmedetomidine in people with Lidocaine and Dexmedetomidine, run by Ain Shams 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 9 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 21 Jul 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?
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?
Total morphine consumption (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 21 Jul 2026.