LaryngoscopyPhase 4NCT06226532
Effect of Lidocaine Sprayed for Attenuating Hemodynamic Response During Laryngoscopy and Intubation
A Phase 4 study testing lidocaine spray and Intravenous Lidocaine in people with Laryngoscopy and Intubation, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to to evaluate the efficacy of lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff compare with intravenous lidocaine on the hemodynamic response to laryngoscopy and intubation in patients undergoing elective neurological procedures during general… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngoscopy, Intubation, Hemodynamics
- What is being tested?
- lidocaine spray and Intravenous Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2024to May 2025
- 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
- Age 18-65 years old
- American Society of Anesthesiologists (ASA) physical status classification I-II
Who cannot join
- History of lidocaine allergy
- Predicted difficult airways
- Body mass index > 35 kilograms per meter squared
- Risk aspiration
- Baseline hemodynamic instability; heart rate < 50 bpm, heart rate > 120 bpm, blood pressure < 90/60 mmHg, blood pressure > 160/90 mmHg
- Underlying disease: epilepsy, cardiovascular disease, heart failure, impaired cardiac function, severe renal dysfunction, impaired hepatic function, peripheral vascular disease
- Pregnancy
- Cerebral aneurysm, Arteriovenous malformation, Tumor size > 4 centimeters, Brain herniation
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Khon Kaen University
Nai Muang, KhonKaen, 40002
Nattawadee Phokaw, M.D., 0619719493, nattapho@kku.ac.th
Nattawadee Phokaw, M.D.
About this study
Official title: Effect of Lidocaine Sprayed at the Laryngeal Inlet and Endotracheal Tube Cuff Versus Intravenous Lidocaine for Attenuating Hemodynamic Response During Laryngoscopy and Intubation in Neurosurgical Patients
The goal of this clinical trial is to to evaluate the efficacy of lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff compare with intravenous lidocaine on the hemodynamic response to laryngoscopy and intubation in patients undergoing elective neurological procedures during general anesthesia with total intravenous technique.
The main question it aims to answer is:
Read more
- Does topical lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff have more effect on stabilizing hemodynamic responses to laryngoscopy and intubation than intravenous lidocaine, in neurosurgical patients who undergo general anesthesia with total intravenous technique?
Participants will be recruited and randomized to receive either lidocaine spray (Group SL) or intravenous lidocaine (group IL) to blunt hemodynamic response to laryngoscopy and intubation.
Read the detailed description
Anesthetic protocol
- Preoperative
- After the informed consent, all eligible patients will be fasting after midnight as it is an elective procedure.
- No preoperative sedatives or analgesics were administered.
- Intraoperative Pre-induction phase
- Standard monitors of electrocardiogram, noninvasive blood pressure (NIBP) is measured at upper extremity with BP cuff bladder length ≥ 80% and width ≥40% of patient's arm circumference and pulse oximeter were attached.
- BIS (Bispectral index) was monitored
- Hemodynamic baseline values of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded before the induction.
Intervention: prepared before induction anesthesia.
- Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg).
- Group IL: 2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).
Induction phase
- Preoxygenation 100% oxygen, flow 6 liters per minute, for 3-5 minutes, target end tidal oxygen more than 90%
- Medication before the induction of anesthesia includes fentanyl 1.5 mcg/kg IV.
- General anesthesia will be induced with propofol target-controlled infusion (TCI) 4-6 mcg/ml IV, followed by cisatracurium 0.15 mg/kg IV for intubation.
- Bag mask ventilation will be started.
- The arterial line will be canulated before direct laryngoscopy and intubation and arterial line pressure transducer will be levelled at the phlebostatic axis and calibrate with NIBP.
- Intervention: Group IL: 2% lidocaine 1.5 mg/kg IV was given 2 minutes after cisatracurium injection.
- Direct laryngoscopy and tracheal intubation were done by an anesthesiologist, 1st (6 months experience), 2nd, and 3rd years anesthesiology resident.
At 5 minutes after cisatracurium injection, direct laryngoscopy will be performed, and spray 10%lidocaine directly to the epiglottis for 4 puffs for SL group.
- Tracheal intubation will be performed.
- The bispectral index (BIS) target range during intubation is 40 to 60.
- The hemodynamic parameters including mean arterial pressure(MAP) in mmHg, systolic blood pressure(SBP) in mmHg, diastolic blood pressure(DBP) in mmHg and heart rate(HR) in beats per minutes(bpm) and BIS will record during the peri-intubation period
All the adverse events (cough, pulmonary aspiration, desaturation, hypotension, hypertension, tachycardia, bradycardia, and arrythmia) will be noted as yes or no.
- Conditions
- Laryngoscopy, Intubation, Hemodynamics, Neurosurgery, Lidocaine
- Being tested
- lidocaine spray, Intravenous Lidocaine
- Keywords
- Lidocaine, Laryngoscopy and intubation, Hemodynamics, Neurosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine sprayDrug
Also called 10% lidocaine spray
Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg)
Intravenous LidocaineDrug
Also called 2%Intravenous Lidocaine
2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).
| Study group | Role | What they receive |
|---|---|---|
| Group SL | Experimental | 10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff, 4 puffs each. Receives: Drug: lidocaine spray |
| Group IL | Active comparator | 2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group. Receives: Drug: Intravenous Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in mean arterial pressure (MAP) during the peri-intubation period
Mean arterial pressure was recorded in mmHg by the anesthesiologist
Measured: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Changing in blood pressure (BP) during the peri-intubation period
Blood pressure was recorded in mmHg by the anesthesiologist
Measured: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Changing in heart rate (HR) during the peri-intubation period
Heart rate was recorded in bpm by the anesthesiologist
Measured: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Secondary outcomes (1)
Incidence of adverse event during laryngoscopy and intubation procedure
Adverse events were recorded by the anesthesiologist. The adverse events included coughing, desaturation, aspiration, hypotension, hypertension, tachycardia, and bradycardia
Measured: During laryngoscopy and intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for LaryngoscopyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Group SL: 10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff. 2. Group IL: 2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattawadee Phokaw, MD, Khon Kaen University
- Investigators
- Nattawadee Phokaw, MD, Principal investigator, Department of anesthesiologist, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226532
- Sponsor's protocol ID
- HE661362
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD)
Publications
Ismail SA, Bisher NA, Kandil HW, Mowafi HA, Atawia HA. Intraocular pressure and haemodynamic responses to insertion of the i-gel, laryngeal mask airway or endotracheal tube. Eur J Anaesthesiol. 2011 Jun;28(6):443-8. doi: 10.1097/EJA.0b013e328345a413.
PubMed 21455075Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.
PubMed 10861145Tada Y, Wada K, Shimada K, Makino H, Liang EI, Murakami S, Kudo M, Kitazato KT, Nagahiro S, Hashimoto T. Roles of hypertension in the rupture of intracranial aneurysms. Stroke. 2014 Feb;45(2):579-86. doi: 10.1161/STROKEAHA.113.003072. Epub 2013 Dec 26.
PubMed 24370755Khan FA, Ullah H. Pharmacological agents for preventing morbidity associated with the haemodynamic response to tracheal intubation. Cochrane Database Syst Rev. 2013 Jul 3;2013(7):CD004087. doi: 10.1002/14651858.CD004087.pub2.
PubMed 23824697Gerlach AT, Murphy CV. Dexmedetomidine-associated bradycardia progressing to pulseless electrical activity: case report and review of the literature. Pharmacotherapy. 2009 Dec;29(12):1492. doi: 10.1592/phco.29.12.1492.
PubMed 19947809Tam S, Chung F, Campbell M. Intravenous lidocaine: optimal time of injection before tracheal intubation. Anesth Analg. 1987 Oct;66(10):1036-8. No abstract available.
PubMed 3631567Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.
PubMed 3828177Lee SY, Min JJ, Kim HJ, Hong DM, Kim HJ, Park HP. Hemodynamic effects of topical lidocaine on the laryngoscope blade and trachea during endotracheal intubation: a prospective, double-blind, randomized study. J Anesth. 2014 Oct;28(5):668-75. doi: 10.1007/s00540-014-1812-z. Epub 2014 Mar 12.
PubMed 24619576
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine Sprayed at the Laryngeal Inlet and Endotracheal Tube Cuff Versus Intravenous Lidocaine for Attenuating Hemodynamic Response During Laryngoscopy and Intubation in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT06226532
- Acronym / sponsor ID
- HE661362
- Conditions
- Laryngoscopy, Intubation, Hemodynamics, Neurosurgery, Lidocaine
- Keywords
- Lidocaine, Laryngoscopy and intubation, Hemodynamics, Neurosurgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 26 Jan 2024 (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 clinical trial is to to evaluate the efficacy of lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff compare with intravenous lidocaine on the hemodynamic response to laryngoscopy and intubation in patients undergoing elective neurological procedures during general anesthesia with total intravenous technique.
The main question it aims to answer is:
- Does topical lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff have more effect on stabilizing hemodynamic responses to laryngoscopy and intubation than intravenous lidocaine, in neurosurgical patients who undergo general anesthesia with total intravenous technique?
Participants will be recruited and randomized to receive either lidocaine spray (Group SL) or intravenous lidocaine (group IL) to blunt hemodynamic response to laryngoscopy and intubation.
Detailed description
Anesthetic protocol
- Preoperative
- After the informed consent, all eligible patients will be fasting after midnight as it is an elective procedure.
- No preoperative sedatives or analgesics were administered.
- Intraoperative Pre-induction phase
- Standard monitors of electrocardiogram, noninvasive blood pressure (NIBP) is measured at upper extremity with BP cuff bladder length ≥ 80% and width ≥40% of patient's arm circumference and pulse oximeter were attached.
- BIS (Bispectral index) was monitored
- Hemodynamic baseline values of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded before the induction.
Intervention: prepared before induction anesthesia.
- Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg).
- Group IL: 2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).
Induction phase
- Preoxygenation 100% oxygen, flow 6 liters per minute, for 3-5 minutes, target end tidal oxygen more than 90%
- Medication before the induction of anesthesia includes fentanyl 1.5 mcg/kg IV.
- General anesthesia will be induced with propofol target-controlled infusion (TCI) 4-6 mcg/ml IV, followed by cisatracurium 0.15 mg/kg IV for intubation.
- Bag mask ventilation will be started.
- The arterial line will be canulated before direct laryngoscopy and intubation and arterial line pressure transducer will be levelled at the phlebostatic axis and calibrate with NIBP.
- Intervention: Group IL: 2% lidocaine 1.5 mg/kg IV was given 2 minutes after cisatracurium injection.
- Direct laryngoscopy and tracheal intubation were done by an anesthesiologist, 1st (6 months experience), 2nd, and 3rd years anesthesiology resident.
At 5 minutes after cisatracurium injection, direct laryngoscopy will be performed, and spray 10%lidocaine directly to the epiglottis for 4 puffs for SL group.
- Tracheal intubation will be performed.
- The bispectral index (BIS) target range during intubation is 40 to 60.
- The hemodynamic parameters including mean arterial pressure(MAP) in mmHg, systolic blood pressure(SBP) in mmHg, diastolic blood pressure(DBP) in mmHg and heart rate(HR) in beats per minutes(bpm) and BIS will record during the peri-intubation period
All the adverse events (cough, pulmonary aspiration, desaturation, hypotension, hypertension, tachycardia, bradycardia, and arrythmia) will be noted as yes or no.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Group SL: 10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff. 2. Group IL: 2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.
| Arm | Type | Receives |
|---|---|---|
| Group SL | Experimental | Drug: lidocaine spray10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff, 4 puffs each. |
| Group IL | Active comparator | Drug: Intravenous Lidocaine2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65 years old
- American Society of Anesthesiologists (ASA) physical status classification I-II
Key exclusion criteria (8 listed)
- History of lidocaine allergy
- Predicted difficult airways
- Body mass index > 35 kilograms per meter squared
- Risk aspiration
- Baseline hemodynamic instability; heart rate < 50 bpm, heart rate > 120 bpm, blood pressure < 90/60 mmHg, blood pressure > 160/90 mmHg
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 sprayAlso: 10% lidocaine sprayGroup SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg) | Drug | Group SL |
| Intravenous LidocaineAlso: 2%Intravenous Lidocaine2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation). | Drug | Group IL |
Primary outcome
Changing in mean arterial pressure (MAP) during the peri-intubation period
Time frame: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Mean arterial pressure was recorded in mmHg by the anesthesiologist
Changing in blood pressure (BP) during the peri-intubation period
Time frame: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Blood pressure was recorded in mmHg by the anesthesiologist
Changing in heart rate (HR) during the peri-intubation period
Time frame: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Heart rate was recorded in bpm by the anesthesiologist
1 secondary outcome
Incidence of adverse event during laryngoscopy and intubation procedure
Time frame: During laryngoscopy and intubation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 21455075Ismail SA, Bisher NA, Kandil HW, Mowafi HA, Atawia HA. Intraocular pressure and haemodynamic responses to insertion of the i-gel, laryngeal mask airway or endotracheal tube. Eur J Anaesthesiol. 2011 Jun;28(6):443-8. doi: 10.1097/EJA.0b013e328345a413.
- Background: PubMed 10861145Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.
- Background: PubMed 24370755Tada Y, Wada K, Shimada K, Makino H, Liang EI, Murakami S, Kudo M, Kitazato KT, Nagahiro S, Hashimoto T. Roles of hypertension in the rupture of intracranial aneurysms. Stroke. 2014 Feb;45(2):579-86. doi: 10.1161/STROKEAHA.113.003072. Epub 2013 Dec 26.
- Background: PubMed 23824697Khan FA, Ullah H. Pharmacological agents for preventing morbidity associated with the haemodynamic response to tracheal intubation. Cochrane Database Syst Rev. 2013 Jul 3;2013(7):CD004087. doi: 10.1002/14651858.CD004087.pub2.
- Background: PubMed 19947809Gerlach AT, Murphy CV. Dexmedetomidine-associated bradycardia progressing to pulseless electrical activity: case report and review of the literature. Pharmacotherapy. 2009 Dec;29(12):1492. doi: 10.1592/phco.29.12.1492.
- Background: PubMed 3631567Tam S, Chung F, Campbell M. Intravenous lidocaine: optimal time of injection before tracheal intubation. Anesth Analg. 1987 Oct;66(10):1036-8. No abstract available.
- Background: PubMed 3828177Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.
- Background: PubMed 24619576Lee SY, Min JJ, Kim HJ, Hong DM, Kim HJ, Park HP. Hemodynamic effects of topical lidocaine on the laryngoscope blade and trachea during endotracheal intubation: a prospective, double-blind, randomized study. J Anesth. 2014 Oct;28(5):668-75. doi: 10.1007/s00540-014-1812-z. Epub 2014 Mar 12.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD)
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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.
Nattawadee Phokaw, MD principal investigator
Department of anesthesiologist, Faculty of Medicine, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine spray and Intravenous Lidocaine in people with Laryngoscopy and Intubation, run by Khon Kaen University at 1 site in Thailand.
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 8 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 26 Jan 2024. 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 Thailand. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nattawadee Phokaw, MD (+66619719493, Nattapho@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing in mean arterial pressure (MAP) during the peri-intubation period (time frame: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation). The study lists 3 primary outcomes in all. 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 NCT06226532, which also lists 8 linked publications.
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 26 Jan 2024.