DexmedetomidineNCT06952309
Intravenous Lidocaine Plus Intratracheal Dexmedetomidine on Postoperative Sore Throat
A study testing Intracheal dexmedetomidine, Intravenous lidocaine and Intravenous lidocaine combined with intracheal dexmedetomidine in people with Dexmedetomidine and Lidocaine, run by Anqing Municipal Hospital.
Trial summary
Objective: The present study was to investigate the effect of intravenous lidocaine combined with intratracheal dexmedetomidine on postoperative sore throat in patients undergoing thyroid cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dexmedetomidine, Lidocaine, Sore Throat
- What is being tested?
- Intracheal dexmedetomidine, Intravenous lidocaine and Intravenous lidocaine combined with intracheal dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2025to 25 Sep 2025
- 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
- Thyroid cancer surgery with ASA grades I-II
- Aged 18-65 years
- The patient's communication is normal and they have a certain learning ability
Who cannot join
- Severe respiratory and circulatory system diseases
- There was bradycardia (HR < 60 beats/minute) or atrioventricular block before the operation
- Nervous system disease
- Mental and psychological disorders
- Abnormal liver and kidney functions
- Pregnant and lactating women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xu Siqi contact
About this study
Official title: Effect of Intravenous Lidocaine Combined With Intratracheal Dexmedetomidine on Postoperative Throat Pain in Patients Undergoing Thyroid Cancer Surgery
Objective: The present study was to investigate the effect of intravenous lidocaine combined with intratracheal dexmedetomidine on postoperative sore throat in patients undergoing thyroid cancer surgery.
Methods: Investigators enrolled 144 patients with American Society of Anesthesiologists (ASA) physical status I and II, aged 18-65 years, and scheduled for elective undergoing thyroid cancer surgery with general anesthesia. The participants were randomly assigned into four groups(n=36 each group): Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia. Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia.The incidence and severity of postoperative sore throat were recorded in four groups at 1 h, 2 h, 6 h, 24 h and 48 h after operation.
- Conditions
- Dexmedetomidine, Lidocaine, Sore Throat
- Being tested
- Intracheal dexmedetomidine, Intravenous lidocaine, Intravenous lidocaine combined with intracheal dexmedetomidine, Saline (NaCl 0,9 %) (placebo)
- Keywords
- dexmedetomidine, lidocaine, thyroid surgery, sore throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracheal dexmedetomidineDrug
Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Intravenous lidocaineDrug
Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Intravenous lidocaine combined with intracheal dexmedetomidineDrug
Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Saline (NaCl 0,9 %) (placebo)Drug
Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine | Experimental | Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia Receives: Drug: Intravenous lidocaine |
| Intracheal dexmedetomidine | Experimental | Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia Receives: Drug: Intracheal dexmedetomidine |
| Intravenous lidocaine combined with intracheal dexmedetomidine | Experimental | Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia Receives: Drug: Intravenous lidocaine combined with intracheal dexmedetomidine |
| Saline | Experimental | Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of postoperative sore throat
Measured: at 1 hour, 2 hour, 6 hour, 24 hour and 48 hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anqing Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952309
- Sponsor's protocol ID
- Xuwen531
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lidocaine Combined With Intratracheal Dexmedetomidine on Postoperative Throat Pain in Patients Undergoing Thyroid Cancer Surgery
- ClinicalTrials.gov ID
- NCT06952309
- Acronym / sponsor ID
- Xuwen531
- Conditions
- Dexmedetomidine, Lidocaine, Sore Throat
- Keywords
- dexmedetomidine, lidocaine, thyroid surgery, sore throat
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 30 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.
Objective: The present study was to investigate the effect of intravenous lidocaine combined with intratracheal dexmedetomidine on postoperative sore throat in patients undergoing thyroid cancer surgery.
Methods: Investigators enrolled 144 patients with American Society of Anesthesiologists (ASA) physical status I and II, aged 18-65 years, and scheduled for elective undergoing thyroid cancer surgery with general anesthesia. The participants were randomly assigned into four groups(n=36 each group): Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia. Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia.The incidence and severity of postoperative sore throat were recorded in four groups at 1 h, 2 h, 6 h, 24 h and 48 h after operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine | Experimental | Drug: Intravenous lidocaineGroup L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia |
| Intracheal dexmedetomidine | Experimental | Drug: Intracheal dexmedetomidineGroup D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia |
| Intravenous lidocaine combined with intracheal dexmedetomidine | Experimental | Drug: Intravenous lidocaine combined with intracheal dexmedetomidineGroup LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia |
| Saline | Experimental | Drug: Saline (NaCl 0,9 %) (placebo)Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Thyroid cancer surgery with ASA grades I-II
- Aged 18-65 years
- The patient's communication is normal and they have a certain learning ability
Key exclusion criteria (6 listed)
- Severe respiratory and circulatory system diseases
- There was bradycardia (HR < 60 beats/minute) or atrioventricular block before the operation
- Nervous system disease
- Mental and psychological disorders
- Abnormal liver and kidney functions
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 |
|---|---|---|
| Intracheal dexmedetomidineGroup D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia | Drug | Intracheal dexmedetomidine |
| Intravenous lidocaineGroup L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia | Drug | Intravenous lidocaine |
| Intravenous lidocaine combined with intracheal dexmedetomidineGroup LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia | Drug | Intravenous lidocaine combined with intracheal dexmedetomidine |
| Saline (NaCl 0,9 %) (placebo)Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia | Drug | Saline |
Primary outcome
The incidence and severity of postoperative sore throat
Time frame: at 1 hour, 2 hour, 6 hour, 24 hour and 48 hour after operation
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 30 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Xu Siqi contact
Questions about this trial
What is this clinical trial studying?
A study testing Intracheal dexmedetomidine, Intravenous lidocaine and Intravenous lidocaine combined with intracheal dexmedetomidine in people with Dexmedetomidine and Lidocaine, run by Anqing Municipal Hospital.
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 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 30 Apr 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.
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 Xu Siqi, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of postoperative sore throat (time frame: at 1 hour, 2 hour, 6 hour, 24 hour and 48 hour after operation). 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 30 Apr 2025.