AnesthesiaNCT05657028
Dexmedetomidine Versus Lidocaine in Attenuating Airway Reflexes During Recovery of Thyroidectomy Patients
A study testing Dexmedetomidine and Lidocaine IV in people with Anesthesia and Airway Complication of Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
It is widely believed that most of the patients experience a cough upon emergence from general anesthesia, due to many causes including the presence of an endotracheal tube, uncleared secretions and anesthetic gas. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Airway Complication of Anesthesia
- What is being tested?
- Dexmedetomidine and Lidocaine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Sep 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective thyroidectomy surgery.
- Age: patients between 18-and 65-years old from both sexes.
- Classified as either American Society of Anesthesiologists (ASA) class I or II.
Who cannot join
- Refusal of procedure or participation in the study.
- Patients suffering from asthma, chronic cough, preoperative upper respiratory infection symptoms.
- Current smoker.
- Medication involving angiotensin-converting-enzyme inhibitors (ACE-I).
- Classified as either American Society of Anesthesiologists (ASA) class III or IV.
- Sinus Bradycardia (<60/min) or history of any type of heart block or Beta-Blockers medication.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams University Hospitals
Cairo, 11511
Ola N Hussain Zaher, MSc, +201003067762, ano_triple@hotmail.com
About this study
Official title: Intravenous Dexmedetomidine Versus Intravenous Lidocaine in Attenuating Airway Reflexes During Recovery of Thyroidectomy Patients
It is widely believed that most of the patients experience a cough upon emergence from general anesthesia, due to many causes including the presence of an endotracheal tube, uncleared secretions and anesthetic gas. Cough during tracheal extubation may lead to several complications, such as hypertension, tachycardia and postoperative bleeding.
In this study the investigators are going to compare the effectiveness of intravenous Dexmedetomidine and intravenous lidocaine in attenuating the air way reflexes and coughing during recovery of thyroidectomy patients.
Read the detailed description
Intubation and extubation process are associated with cardiovascular and various airway responses leading to tachycardia, hypertension, arrhythmia, myocardial ischemia, cough induction, bronchospasm, increased bleeding, increased intracranial and intraocular pressure. Causes possibly include the presence of an endotracheal tube, uncleared secretions, and anesthetic gas.
Furthermore, postoperative bleeding in thyroid surgery is still significant and is often associated with severe complications including cervical hematoma, reoperation and cardiac arrest.
Extubation under deep anesthesia decreases cardiovascular stimulation and reduces the incidence of coughing and straining on the tube. Intratracheal local anesthetic instillation, I.V lidocaine, short acting opioids such as fentanyl and remifentanil, esmolol, labetalol, diltiazem and verapamil have been used to attenuate these hemodynamic and respiratory responses during extubation in the past but with certain limitations.
Also "no stimulation" extubation technique avoids extubation under light anesthesia and ensures extubation only when consciousness is returned. It requires absolutely no stimulation during emergence and performing extubation only when the patient wakes up spontaneously and opens his eyes.
Recently dexmedetomidine, a potent α2-adrenoreceptor agonist has been used to facilitate extubation in surgical intensive care unit, but its role in the attenuation of hemodynamic and airway reflexes during extubation in general anesthesia is still under study.
In this study the investigators are going to compare the effects of intravenous lidocaine and dexmedetomidine in inhibiting cough reflex during the recovery period after thyroid surgery.
- Conditions
- Anesthesia, Airway Complication of Anesthesia
- Being tested
- Dexmedetomidine, Lidocaine IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
-In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine 0.5 μg/kg over 10 min before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4 μg/kg/hour until 30 min before the end of surgery.
Lidocaine IVDrug
In the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine (2%)1.5mg/kg over 10 min before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg /hour until 30 min before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group D (Dexmedetomidine) | Experimental | In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine Receives: Drug: Dexmedetomidine |
| Group L (Lidocaine) | Experimental | In the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine Receives: Drug: Lidocaine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare effectiveness of Dexmedetomidine and intravenous lidocaine in attenuating cough reflex during the tracheal extubation period after thyroid surgery
the investigators use the following cough score where 0 = no cough, 1 = minimal (single) cough, 2 = moderate (≤5 seconds) cough and 3 = severe (>5 seconds) cough to reflect the degree of attenuation of air way reflexes for each group
Measured: 5 minutes from extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Sep 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657028
- Sponsor's protocol ID
- attenuating airway reflexes
- Status last verified
- Jan 2023
- First submitted
- 8 Nov 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu S, Li Y, Wang S, Xu S, Ju X, Ma L. Effects of intravenous infusion of lidocaine and dexmedetomidine on inhibiting cough during the tracheal extubation period after thyroid surgery. BMC Anesthesiol. 2019 May 4;19(1):66. doi: 10.1186/s12871-019-0739-1.
PubMed 31054568
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexmedetomidine Versus Intravenous Lidocaine in Attenuating Airway Reflexes During Recovery of Thyroidectomy Patients
- ClinicalTrials.gov ID
- NCT05657028
- Acronym / sponsor ID
- attenuating airway reflexes
- Conditions
- Anesthesia, Airway Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 20 Dec 2022 (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.
It is widely believed that most of the patients experience a cough upon emergence from general anesthesia, due to many causes including the presence of an endotracheal tube, uncleared secretions and anesthetic gas. Cough during tracheal extubation may lead to several complications, such as hypertension, tachycardia and postoperative bleeding.
In this study the investigators are going to compare the effectiveness of intravenous Dexmedetomidine and intravenous lidocaine in attenuating the air way reflexes and coughing during recovery of thyroidectomy patients.
Detailed description
Intubation and extubation process are associated with cardiovascular and various airway responses leading to tachycardia, hypertension, arrhythmia, myocardial ischemia, cough induction, bronchospasm, increased bleeding, increased intracranial and intraocular pressure. Causes possibly include the presence of an endotracheal tube, uncleared secretions, and anesthetic gas.
Furthermore, postoperative bleeding in thyroid surgery is still significant and is often associated with severe complications including cervical hematoma, reoperation and cardiac arrest.
Extubation under deep anesthesia decreases cardiovascular stimulation and reduces the incidence of coughing and straining on the tube. Intratracheal local anesthetic instillation, I.V lidocaine, short acting opioids such as fentanyl and remifentanil, esmolol, labetalol, diltiazem and verapamil have been used to attenuate these hemodynamic and respiratory responses during extubation in the past but with certain limitations.
Also "no stimulation" extubation technique avoids extubation under light anesthesia and ensures extubation only when consciousness is returned. It requires absolutely no stimulation during emergence and performing extubation only when the patient wakes up spontaneously and opens his eyes.
Recently dexmedetomidine, a potent α2-adrenoreceptor agonist has been used to facilitate extubation in surgical intensive care unit, but its role in the attenuation of hemodynamic and airway reflexes during extubation in general anesthesia is still under study.
In this study the investigators are going to compare the effects of intravenous lidocaine and dexmedetomidine in inhibiting cough reflex during the recovery period after thyroid surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Dexmedetomidine) | Experimental | Drug: DexmedetomidineIn the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine |
| Group L (Lidocaine) | Experimental | Drug: Lidocaine IVIn the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective thyroidectomy surgery.
- Age: patients between 18-and 65-years old from both sexes.
- Classified as either American Society of Anesthesiologists (ASA) class I or II.
Key exclusion criteria (6 listed)
- Refusal of procedure or participation in the study.
- Patients suffering from asthma, chronic cough, preoperative upper respiratory infection symptoms.
- Current smoker.
- Medication involving angiotensin-converting-enzyme inhibitors (ACE-I).
- Classified as either American Society of Anesthesiologists (ASA) class III or IV.
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-In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine 0.5 μg/kg over 10 min before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4 μg/kg/hour until 30 min before the end of surgery. | Drug | Group D (Dexmedetomidine) |
| Lidocaine IVIn the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine (2%)1.5mg/kg over 10 min before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg /hour until 30 min before the end of surgery. | Drug | Group L (Lidocaine) |
Primary outcome
compare effectiveness of Dexmedetomidine and intravenous lidocaine in attenuating cough reflex during the tracheal extubation period after thyroid surgery
Time frame: 5 minutes from extubation
the investigators use the following cough score where 0 = no cough, 1 = minimal (single) cough, 2 = moderate (≤5 seconds) cough and 3 = severe (>5 seconds) cough to reflect the degree of attenuation of air way reflexes for each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Results publication: PubMed 31054568Hu S, Li Y, Wang S, Xu S, Ju X, Ma L. Effects of intravenous infusion of lidocaine and dexmedetomidine on inhibiting cough during the tracheal extubation period after thyroid surgery. BMC Anesthesiol. 2019 May 4;19(1):66. doi: 10.1186/s12871-019-0739-1.
- 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. This study is not recruiting at the moment.
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 and Lidocaine IV in people with Anesthesia and Airway Complication of Anesthesia, 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 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: status not confirmed, as of the sponsor's last update on 1 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ola N Hussain Zaher, MSC (+201003067762, ano_triple@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare effectiveness of Dexmedetomidine and intravenous lidocaine in attenuating cough reflex during the tracheal extubation period after thyroid surgery (time frame: 5 minutes from extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657028, which also lists 1 linked publication.
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 1 Feb 2023.