Hemodynamic InstabilityPhase 4NCT04659057
Nebulized Lidocaine, Dexmedetomedine and Their Combination in Direct Laryngoscopy Surgery
A Phase 4 study testing Nebulized Lidocaine, Nebulized dexmedetomidine and Nebulized lidocaine and dexmedetomidine in people with Hemodynamic Instability, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Direct laryngoscopy (DL) procedure is typically done under general anaesthesia as a day case. It is a short but irritating.Various drugs and drug combinations have been used to attenuate stress response to DL.Administrating nebulized form of drugs can be effective with less systemic side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Nebulized Lidocaine, Nebulized dexmedetomidine and Nebulized lidocaine and dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesEgypt
- Study dates
- 12 Dec 2020to 11 Jul 2021
- Phase
- Phase 4
- 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
- ASA I-III patients admitted for DL surgery.
Who cannot join
- Uncontrolled hypertension (MAP > 100 mmHg) or ischaemic heart disease.
- End stage renal impairment.
- Chronic drug or alcohol abuse.
- Predicted difficult airway, laryngoscopy and intubation time > 30 sec, more than one attempt of intubation.
- Morbid obesity (BMI > 30).
- Known allergy to the drugs used.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain Shams University
Cairo, Cairo Governorate, 11566
Ain Shams University Hospitals
Cairo, 11588
About this study
Official title: Effect of Nebulized Lidocaine, Dexmedetomedine and Their Combination on Haemodynamics During Direct Laryngoscopy Surgery. A Randomized Controlled Clinical Trial.
Direct laryngoscopy (DL) procedure is typically done under general anaesthesia as a day case. It is a short but irritating.Various drugs and drug combinations have been used to attenuate stress response to DL.Administrating nebulized form of drugs can be effective with less systemic side effects. The primary outcome of this study is to compare the effect of premedication with nebulized lidocaine, dexmedetomidine, combination of both to placebo on haemodynamic response during DL procedures.
Read the detailed description
Patients will be transferred to the induction room 30 min prior to surgery. Standard monitors will be applied [pulse oximetry, non invasive blood pressure (NIBP) and electrocardiogram (ECG)]. Basal HR, systolic (SBP), diastolic (DBP) and mean arterial blood pressure (MAP) will be recorded. An intravenous 22-G cannula will be inserted, and all patients will be pre-medicated with intravenous midazolam 0.02 mg/kg, granisetrone 2mg and ranitidine 30 mg.
Patients will then be randomly and evenly allocated to one of 4 groups (45 patients each).
Nebulized solutions will be prepared by a pharmacist not participating in the study. Nebulization will be done with 100% oxygen (10 L/min) through facemask attached to a nebulizer. Patients will be asked to breath normally. Nebulization will continue till the solution in the nebulizer is all aerosolized.
Upon arrival to the operating room, routine monitors will be applied in addition to neuromuscular monitor and end tidal CO2 (ETCO2). General anaesthesia will be induced, after 5 min of preoxygenation, by intravenous fentanyl 1 μg/kg, propofol 1.5-2 mg/kg titrated to a loss of verbal response and rocuronium 1 mg/kg to facilitate endotracheal intubation. Mackintosh laryngoscope will be introduced when train of four (TOF) count reaches 1. High volume-low pressure endotracheal tube (size 5-5.5) will be inserted by senior anaesthesiologist. HR, SBP, DBP and MAP will be recorded immediately after intubation.
Anaesthesia will be maintained by sevoflurane 2-3% in oxygen to air ratio 1:1. Rocuronium 0.1 mg/kg when required. Positive pressure ventilation will be set to maintain ETCO2 30-35 mmHg.
SBP, DBP, MAP and HR will be recorded on arrival to the induction room (baseline), after endotracheal intubation, and then every 5 min throughout the surgery.
In case of hypertension (defined as SBP > 140 mmHg, DBP >90 mmHg or MAP 20% higher than baseline) and/or tachycardia (defined as HR 20% higher than baseline), boluses fentanyl 0.5 μg/kg will be given with a maximum dose of 2 μg/Kg. If hypertension and/or tachycardia continue after reaching the maximum dose of fentanyl, loading dose of esmolol 500 μg/Kg will be started, followed by infusion of 100-300 μg/kg/min. The use and total dose of esmolol will be recorded.
In cases of significant hypotension (defined as mean blood pressure < 70 mmHg), the patient will be treated initially with an intravenous (IV) fluid bolus of10 mL/kg normal saline, and if the condition persists, the patient will given 0.1-0.3 mg/kg IV ephedrine, which will be repeated every 3-5 minutes until the blood pressure is normalized. Significant bradycardia (defined as heart rate < 60 beat/min) will be treated, when needed, with IV atropine 0.02 mg/kg.
At the conclusion of surgery, sevoflurane will be discontinued and patients will inhale 100% O2. After return of spontaneous breathing, residual neuromuscular block will be reversed with intravenous neostigmine 0.05 mg/kg and glycopyrolate 0.01 mg/kg. Extubation will be done when the patient starts to show purposeful movements.
- Conditions
- Hemodynamic Instability
- Being tested
- Nebulized Lidocaine, Nebulized dexmedetomidine, Nebulized lidocaine and dexmedetomidine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized LidocaineDrug
Also called Lidocaine group
will receive nebulized lidocaine 2%, 1 mg/kg with a maximum dose of 100 mg (5 ml).
Nebulized dexmedetomidineDrug
Also called Dexmedetomidine group
will receive nebulized dexmedetomidine (1 μg/kg diluted in 5 ml of saline 0.9%).
Nebulized lidocaine and dexmedetomidineDrug
Also called Combined lidocaine and dexmedetomidine group
will receive nebulized lidocaine 2% (0.5 mg/kg) and dexmedetomidine 0.5 μg/kg dexmedetomidine in 5 ml of saline 0.9%.
PlaceboOther
Also called Control group
will receive nebulized saline 0.9% (5 ml) as control group.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Lidocaine group; 45 randomly assigned patients. Receives: Drug: Nebulized Lidocaine |
| Group D | Active comparator | Demedetomidine group; 45 randomly assigned patients. Receives: Drug: Nebulized dexmedetomidine |
| Group DL | Active comparator | Combined lidocaine and dexmedetomidine group. 45 randomly assigned patients. Receives: Drug: Nebulized lidocaine and dexmedetomidine |
| Group C | Placebo comparator | Control group; 45 randomly assigned patients. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart rate in beats/min
Measured: Every 5 minutes for 30-60minutes
Systolic blood pressure
Systolic blood pressure in mmHg
Measured: Every 5 minutes for 30-60 minutes
Diastolic blood pressure
Diastolic blood pressure in mmHg
Measured: Every 5 minutes for 30-60 minutes
Mean arterial pressure
Mean arterial pressure in mmHg
Measured: Every 5 min for 30-60 minutes
Secondary outcomes (2)
Total fentanyl and esmolol consumption
The total dose of fentanyl and/or esmolol consumed by each patient
Measured: For 30-60 minutes
recovery time
The time from discontinuation of anaesthetic drugs until response to verbal commands
Measured: 5- 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start12 Dec 2020
- Primary completion11 Jul 2021
- Study completion11 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Salah El-Din El-Ozairy, MD, Ain Shams University
- Investigators
- Hala S El-Ozairy, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659057
- Sponsor's protocol ID
- FMASU R 110/2020
- Status last verified
- Jul 2021
- First submitted
- 23 Nov 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nebulized Lidocaine, Dexmedetomedine and Their Combination on Haemodynamics During Direct Laryngoscopy Surgery. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04659057
- Acronym / sponsor ID
- FMASU R 110/2020
- Conditions
- Hemodynamic Instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 11 Jul 2021 (actual)
- Study completion
- 11 Jul 2021 (actual)
- First posted
- 9 Dec 2020 (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.
Direct laryngoscopy (DL) procedure is typically done under general anaesthesia as a day case. It is a short but irritating.Various drugs and drug combinations have been used to attenuate stress response to DL.Administrating nebulized form of drugs can be effective with less systemic side effects. The primary outcome of this study is to compare the effect of premedication with nebulized lidocaine, dexmedetomidine, combination of both to placebo on haemodynamic response during DL procedures.
Detailed description
Patients will be transferred to the induction room 30 min prior to surgery. Standard monitors will be applied [pulse oximetry, non invasive blood pressure (NIBP) and electrocardiogram (ECG)]. Basal HR, systolic (SBP), diastolic (DBP) and mean arterial blood pressure (MAP) will be recorded. An intravenous 22-G cannula will be inserted, and all patients will be pre-medicated with intravenous midazolam 0.02 mg/kg, granisetrone 2mg and ranitidine 30 mg.
Patients will then be randomly and evenly allocated to one of 4 groups (45 patients each).
Nebulized solutions will be prepared by a pharmacist not participating in the study. Nebulization will be done with 100% oxygen (10 L/min) through facemask attached to a nebulizer. Patients will be asked to breath normally. Nebulization will continue till the solution in the nebulizer is all aerosolized.
Upon arrival to the operating room, routine monitors will be applied in addition to neuromuscular monitor and end tidal CO2 (ETCO2). General anaesthesia will be induced, after 5 min of preoxygenation, by intravenous fentanyl 1 μg/kg, propofol 1.5-2 mg/kg titrated to a loss of verbal response and rocuronium 1 mg/kg to facilitate endotracheal intubation. Mackintosh laryngoscope will be introduced when train of four (TOF) count reaches 1. High volume-low pressure endotracheal tube (size 5-5.5) will be inserted by senior anaesthesiologist. HR, SBP, DBP and MAP will be recorded immediately after intubation.
Anaesthesia will be maintained by sevoflurane 2-3% in oxygen to air ratio 1:1. Rocuronium 0.1 mg/kg when required. Positive pressure ventilation will be set to maintain ETCO2 30-35 mmHg.
SBP, DBP, MAP and HR will be recorded on arrival to the induction room (baseline), after endotracheal intubation, and then every 5 min throughout the surgery.
In case of hypertension (defined as SBP > 140 mmHg, DBP >90 mmHg or MAP 20% higher than baseline) and/or tachycardia (defined as HR 20% higher than baseline), boluses fentanyl 0.5 μg/kg will be given with a maximum dose of 2 μg/Kg. If hypertension and/or tachycardia continue after reaching the maximum dose of fentanyl, loading dose of esmolol 500 μg/Kg will be started, followed by infusion of 100-300 μg/kg/min. The use and total dose of esmolol will be recorded.
In cases of significant hypotension (defined as mean blood pressure < 70 mmHg), the patient will be treated initially with an intravenous (IV) fluid bolus of10 mL/kg normal saline, and if the condition persists, the patient will given 0.1-0.3 mg/kg IV ephedrine, which will be repeated every 3-5 minutes until the blood pressure is normalized. Significant bradycardia (defined as heart rate < 60 beat/min) will be treated, when needed, with IV atropine 0.02 mg/kg.
At the conclusion of surgery, sevoflurane will be discontinued and patients will inhale 100% O2. After return of spontaneous breathing, residual neuromuscular block will be reversed with intravenous neostigmine 0.05 mg/kg and glycopyrolate 0.01 mg/kg. Extubation will be done when the patient starts to show purposeful movements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: Nebulized LidocaineLidocaine group; 45 randomly assigned patients. |
| Group D | Active comparator | Drug: Nebulized dexmedetomidineDemedetomidine group; 45 randomly assigned patients. |
| Group DL | Active comparator | Drug: Nebulized lidocaine and dexmedetomidineCombined lidocaine and dexmedetomidine group. 45 randomly assigned patients. |
| Group C | Placebo comparator | Other: PlaceboControl group; 45 randomly assigned patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III patients admitted for DL surgery.
Key exclusion criteria (6 listed)
- Uncontrolled hypertension (MAP > 100 mmHg) or ischaemic heart disease.
- End stage renal impairment.
- Chronic drug or alcohol abuse.
- Predicted difficult airway, laryngoscopy and intubation time > 30 sec, more than one attempt of intubation.
- Morbid obesity (BMI > 30).
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 |
|---|---|---|
| Nebulized LidocaineAlso: Lidocaine groupwill receive nebulized lidocaine 2%, 1 mg/kg with a maximum dose of 100 mg (5 ml). | Drug | Group L |
| Nebulized dexmedetomidineAlso: Dexmedetomidine groupwill receive nebulized dexmedetomidine (1 μg/kg diluted in 5 ml of saline 0.9%). | Drug | Group D |
| Nebulized lidocaine and dexmedetomidineAlso: Combined lidocaine and dexmedetomidine groupwill receive nebulized lidocaine 2% (0.5 mg/kg) and dexmedetomidine 0.5 μg/kg dexmedetomidine in 5 ml of saline 0.9%. | Drug | Group DL |
| PlaceboAlso: Control groupwill receive nebulized saline 0.9% (5 ml) as control group. | Other | Group C |
Primary outcome
Heart Rate
Time frame: Every 5 minutes for 30-60minutes
Heart rate in beats/min
Systolic blood pressure
Time frame: Every 5 minutes for 30-60 minutes
Systolic blood pressure in mmHg
Diastolic blood pressure
Time frame: Every 5 minutes for 30-60 minutes
Diastolic blood pressure in mmHg
Mean arterial pressure
Time frame: Every 5 min for 30-60 minutes
Mean arterial pressure in mmHg
2 secondary outcomes
Total fentanyl and esmolol consumption
Time frame: For 30-60 minutes
recovery time
Time frame: 5- 15 minutes
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 13 Jul 2021.
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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.
Hala S El-Ozairy, MD principal investigator
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized Lidocaine, Nebulized dexmedetomidine and Nebulized lidocaine and dexmedetomidine in people with Hemodynamic Instability, run by Ain Shams University at 2 sites 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Heart Rate (time frame: Every 5 minutes for 30-60minutes). The study lists 4 primary outcomes in all. 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 13 Jul 2021.