CoughPhase 2NCT06040034
Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients
A Phase 2 study testing Lidocaine IV in people with Cough, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
The goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cough
- What is being tested?
- Lidocaine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Feb 2023to 1 May 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA class 1 and 2
- Thyroidectomy patients in Hasan Sadikin Bandung Hospital
Who cannot join
- Subjects' refusal
- Had history of drug allergy, specifically lidaocaine
- Had history of asthma or other lung diseases
- Active smoker
- History of arrhythmia
- Bradycardia subjects (<60 beats per minute)
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- Pregnant people
- Perioperative upper respiratory tract infusion
- Routinely consume ACE inhibitor / bronchodilators / steroid
- Renal dysfunction
- Liver dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients
The goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. The main questions it aims to answer are:
- Cough incidence on both groups
- Which method is preferable to reduce post-extubation cough incidence
- Conditions
- Cough
- Being tested
- Lidocaine IV
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IVDrug
Lidocaine given as bolus or continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Lidocaine Intravenous Infusion | Active comparator | Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe. Receives: Drug: Lidocaine IV |
| Bolus Lidocaine Intravenous | Active comparator | Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump. Receives: Drug: Lidocaine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Extubation Cough Grade
Cough graded according to the following criteria:
Grade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, >1 cough lasting <5 seconds; Grade 3: coughing heavily and continuously for >5 seconds)
Measured: 24 hours post operative
Secondary outcomes (4)
Number of participant experiencing tachycardia
Tachycardia is defined as heart rate >100 beats per minute
Measured: 24 hours perioperative
Number of participant experiencing bradycardia
Bradycardia is defined as heart rate <60 beats per minute
Measured: 24 hours perioperative
Number of participant experiencing hypertension
Increase of blood pressure >20% from initial blood pressure
Measured: 24 hours perioperative
Number of participant experiencing hypotension
Decrease of blood pressure <20% from initial blood pressure
Measured: 24 hours perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start2 Feb 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iwan Fuadi, MD, Study director, Faculty of Medicine Universitas Padjadjaran BandungArdi Zulfariansyah, MD, Study director, Faculty of Medicine Universitas Padjadjaran BandungIgnatia K Hallis, MD, Principal investigator, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040034
- Sponsor's protocol ID
- AN-202309.01
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients
- ClinicalTrials.gov ID
- NCT06040034
- Acronym / sponsor ID
- AN-202309.01
- Conditions
- Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 15 Sep 2023 (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 goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. The main questions it aims to answer are:
- Cough incidence on both groups
- Which method is preferable to reduce post-extubation cough incidence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Comparison
| Arm | Type | Receives |
|---|---|---|
| Continuous Lidocaine Intravenous Infusion | Active comparator | Drug: Lidocaine IVPatients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe. |
| Bolus Lidocaine Intravenous | Active comparator | Drug: Lidocaine IVPatients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA class 1 and 2
- Thyroidectomy patients in Hasan Sadikin Bandung Hospital
Key exclusion criteria (11 listed)
- Subjects' refusal
- Had history of drug allergy, specifically lidaocaine
- Had history of asthma or other lung diseases
- Active smoker
- History of arrhythmia
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 IVLidocaine given as bolus or continuous infusion. | Drug | Bolus Lidocaine Intravenous, Continuous Lidocaine Intravenous Infusion |
Primary outcome
Post-Extubation Cough Grade
Time frame: 24 hours post operative
Cough graded according to the following criteria: Grade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, >1 cough lasting <5 seconds; Grade 3: coughing heavily and continuously for >5 seconds)
4 secondary outcomes
Number of participant experiencing tachycardia
Time frame: 24 hours perioperative
Number of participant experiencing bradycardia
Time frame: 24 hours perioperative
Number of participant experiencing hypertension
Time frame: 24 hours perioperative
Number of participant experiencing hypotension
Time frame: 24 hours perioperative
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 22 Sep 2023.
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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.
Iwan Fuadi, MD study director
Faculty of Medicine Universitas Padjadjaran Bandung
Ardi Zulfariansyah, MD study director
Faculty of Medicine Universitas Padjadjaran Bandung
Ignatia K Hallis, MD principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
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 IV in people with Cough, run by Universitas Padjadjaran at 1 site in Indonesia.
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 2 inclusion and 11 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 22 Sep 2023. 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 Indonesia. 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?
Post-Extubation Cough Grade (time frame: 24 hours post operative). 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 22 Sep 2023.