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AzTrials

Anesthesia Intubation ComplicationNCT05941767

Dexmedetomidine or Lidocaine for Lessening the Hemodynamic Responses to Laryngoscopy and Intubation

A study testing Dexmedetomidine nebulization, Lidocaine nebulization and Dexmedetomidine IV in people with Anesthesia Intubation Complication, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Anesthesia Intubation Complication
What is being tested?
Dexmedetomidine nebulization, Lidocaine nebulization and Dexmedetomidine IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
12 Jul 2023to 3 Jan 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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The American Society of Anesthesiologists (ASA) physical status I \& II. BMI: ((≤ 35 kg/m2)). The patients are to be scheduled to undergo elective surgery under general anesthesia.
  • Mallampati grade I, II

Who cannot join

  • Uncooperative patient. History of allergy to study drugs. Hemodynamically unstable patient. Renal or hepatic dysfunction or hypertensive patients.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of medicine, Zagazig University

    Zagazig, Al-Sharkia, 055

Other trials in Egypt

About this study

Official title: Comparing Intravenous Versus Nebulized Either Lidocaine or Dexmedetomidine for Attenuation of the Hemodynamic Responses to Laryngoscopy and Intubation

Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Read the detailed description

Hemodynamic responses to laryngoscopy and intubation are a significant concern for the anesthesiologist. Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. These hemodynamic derangements can be lethal in patients with multiple comorbidities. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Being tested
Dexmedetomidine nebulization, Lidocaine nebulization, Dexmedetomidine IV, Lidocaine IV
Keywords
Dexmedetomidine, Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine nebulizationDrug

    Also called Precedex (200 mcg/2ml)

    The patient will receive nebulized dexmedetomidine via face mask nebulizer 10 minutes before induction of general anesthesia.

  • Lidocaine nebulizationDrug

    Also called Lidocaine 2% (20 mg/ml)

    The patient will receive nebulized lidocaine 4% (3 mg /kg) 10 minutes before induction of general anesthesia.

  • Dexmedetomidine IVDrug

    Also called Precedex

    The patient will receive intravenous infusion via a syringe pump of dexmedetomidine (1 ml= 4mcg) started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.

  • Lidocaine IVDrug

    Also called Lidocaine 2% (20 mg/ml)

    The patient will receive 1.5 mg/kg lidocaine 2% (1 ml = 20mg) completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia.

Study groups in NCT05941767
Study groupRoleWhat they receive
Dexmedetomidine nebulizationActive comparatorThe patient will receive nebulized dexmedetomidine via face mask nebulizer (1mcg/kg) 20 minutes before induction.
Receives: Drug: Dexmedetomidine nebulization
Lidocaine NebulizationActive comparatorThe patient will receive nebulized lidocaine 4% (3 mg /kg) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia.
Receives: Drug: Lidocaine nebulization
Dexmedetomidine IVActive comparatorThe patient will receive an intravenous infusion of dexmedetomidine (1 ml= 4 mcg) via a syringe pump and will be started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.
Receives: Drug: Dexmedetomidine IV
Lidocaine IVActive comparatorThe patient will receive 1.5mg/kg intravenous lidocaine 2% completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia.
Receives: Drug: Lidocaine IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum cortisol levels.

    Base line blood sample will be drawn 45 minutes preoperative and 10 minutes post intubation for cortisol level measurements.

    Measured: Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation.

  2. Change in mean arterial blood pressure (MAP) in mmHg.

    Mean arterial pressure (MAP) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

    Measured: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

  3. Change in heart rate (HR) per minute.

    Heart rate (HR) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

    Measured: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

  4. Change in systolic blood pressure (SBP) in mmHg.

    Systolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

    Measured: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

  5. Change in diastolic blood pressure (DBP) in mmHg.

    Diastolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

    Measured: Measurement will be done 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start12 Jul 2023
  3. Primary completion5 Nov 2023
  4. Study completion3 Jan 2024

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941767
Sponsor's protocol ID
Stress Response to intubation
Status last verified
Jan 2024
First submitted
4 Jul 2023
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sriramka B, Warsi ZH, Sahoo J. Effects of adding dexmedetomidine to nebulized lidocaine on control of hemodynamic responses to laryngoscopy and intubation: A randomized clinical trial. J Anaesthesiol Clin Pharmacol. 2023 Jan-Mar;39(1):11-17. doi: 10.4103/joacp.JOACP_93_21. Epub 2022 Feb 10.

    PubMed 37250266

  • Misra S, Behera BK, Mitra JK, Sahoo AK, Jena SS, Srinivasan A. Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial. Korean J Anesthesiol. 2021 Apr;74(2):150-157. doi: 10.4097/kja.20153. Epub 2020 May 20.

    PubMed 32434291

  • Mahajan L, Kaur M, Gupta R, Aujla KS, Singh A, Kaur A. Attenuation of the pressor responses to laryngoscopy and endotracheal intubation with intravenous dexmedetomidine versus magnesium sulphate under bispectral index-controlled anaesthesia: A placebo-controlled prospective randomised trial. Indian J Anaesth. 2018 May;62(5):337-343. doi: 10.4103/ija.IJA_1_18.

    PubMed 29910490

  • Soltani Mohammadi S, Maziar A, Saliminia A. Comparing Clonidine and Lidocaine on Attenuation of Hemodynamic Responses to Laryngoscopy and Tracheal Intubation in Controlled Hypertensive Patients: A Randomized, Double-Blinded Clinical Trial. Anesth Pain Med. 2016 Mar 27;6(2):e34271. doi: 10.5812/aapm.34271. eCollection 2016 Apr.

    PubMed 27247914

  • Mahjoubifard M, Heidari M, Dahmardeh M, Mirtajani SB, Jahangirifard A. Comparison of Dexmedetomidine, Lidocaine, and Fentanyl in Attenuation Hemodynamic Response of Laryngoscopy and Intubation in Patients Undergoing Cardiac Surgery. Anesthesiol Res Pract. 2020 Jul 1;2020:4814037. doi: 10.1155/2020/4814037. eCollection 2020.

    PubMed 32695159

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine nebulization, Lidocaine nebulization and Dexmedetomidine IV in people with Anesthesia Intubation Complication, run by Zagazig 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 2 inclusion and 1 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 28 Feb 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 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?

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?

Change in serum cortisol levels. (time frame: Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation.). The study lists 5 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 NCT05941767, which also lists 5 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 28 Feb 2024.

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