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Intubation ComplicationPhase 1NCT06516861

Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels

A Phase 1 study testing Magnesium Sulfate 20 MG/ML, Lidocaine IV and saline solution in people with Intubation Complication, run by Arsil Radiansyah at 1 site in Indonesia.

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

The sample was randomly divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. These groups will be checked for hemodynamic changes and cortisol values. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Intubation Complication
What is being tested?
Magnesium Sulfate 20 MG/ML, Lidocaine IV and saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteIndonesia
Study dates
31 Jan 2024to 1 Mar 2024
Phase
Phase 1
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 aged 18-65 years;
  • body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2;
  • patients or their families agreed to be used as research subjects;
  • elective non-traumatic craniotomy cases, namely supratentorial brain tumor evacuation, intracerebral hemorrhage evacuation, subdural hemorrhage, cerebrovascular correction.

Who cannot join

  • cardiac, hepatic, and renal disorders;
  • patients with pregnancy;
  • hypertension or hypotension before surgery;
  • hypersensitivity to Magnesium Sulfate and/or Lidocaine;
  • patients with chronic use of corticosteroid drugs, calcium channel blockers, magnesium-containing drugs, and opioids;
  • risk of difficult intubation and ventilation according to the LEMON score and MOANS score criteria;
  • impaired cortisol secretion (pituitary tumor or hypothalamic tumor or adrenal gland disorder); and
  • patients with hypocortisol or hypercortisol at T0 serum cortisol examination.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Adam Malik General Hospital

    Medan, North Sumatra, 20136

Other trials in Indonesia

About this study

Official title: Comparison of Magnesium Sulphate 30 mg/Kg With Lidocaine 1,5 mg/Kg in Hemodynamic Changes and Cortisol Level Post-intubation in Patient Undergoing Craniotomy

The sample was randomly divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. These groups will be checked for hemodynamic changes and cortisol values.

Read the detailed description

The sample was randomly divided into 3 groups and divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. The first group of patients was given Magnesium Sulfate 30 mg /kg diluted in 20 ml with NaCl 0.9%, labeled with code A, and given in 5 minutes with a syringe pump, The second group was given Lidocaine 1.5 mg/kg diluted in 20 ml with NaCl 0.9%, labeled with code B and given in 5 minutes with a syringe pump, The third group was given NaCl 0.9%, in a 20 ml syringe labeled with code C and given in 5 minutes with a syringe pump. After induction and intubation, patients were then recorded systolic blood pressure, diastolic blood pressure, MAP, and pulse at T1 (3 minutes), T2 (5 minutes), T3 (7 minutes), and T4 (10 minutes).

Being tested
Magnesium Sulfate 20 MG/ML, Lidocaine IV, saline solution
Keywords
Craniotomy, Intubation, Lidocaine, MgSO4

What participants receive

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

  • Magnesium Sulfate 20 MG/MLDrug

    Also called Magnesium sulfate injection

    Administered intravenously with a dose of 30 mg/kg

  • Lidocaine IVDrug

    Also called Lidocaine

    Administered intravenously with a dose of 1.5mg/Kg

  • saline solutionDrug

    Also called NaCl 0,9% Solution

    Administered intravenously with 20 ml

Study groups in NCT06516861
Study groupRoleWhat they receive
MgSO4 intravenousExperimentalSample will be given MgSO4 30mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery
Receives: Drug: Magnesium Sulfate 20 MG/ML
Lidocaine intravenousExperimentalSample will be given Lidocain 1.5mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery
Receives: Drug: Lidocaine IV
NaCl 0,9% IntravenousPlacebo comparatorSample will be given NaCl 0,9% Intravenous 20 ml as a premedication drugs before intubation for all patients who had craniotomy surgery
Receives: Drug: saline solution

What is being measured

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

  1. Systolic Blood Pressure

    mmHg

    Measured: 1 month

  2. Diastolic Blood Pressure

    mmHg

    Measured: 1 month

  3. Mean Arterial Pressure (MAP)

    Estimated by using a formula in which the lower (diastolic) blood pressure is doubled and added to the higher (systolic) blood pressure and that composite sum then is divided by 3 to estimate MAP

    Measured: 1 month

  4. Heart Rate

    beats per minute

    Measured: 1 month

Secondary outcomes (1)

  1. Cortisol Levels

    Cortisol Levels in nmol/L

    Measured: 1 month

Timeline

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

  1. First posted24 Jul 2024
  2. Study start31 Jan 2024
  3. Primary completion1 Feb 2024
  4. Study completion1 Mar 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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The design of this study used a double-blind randomized controlled clinical trial with pre test post test with control group design, to assess the comparison of hemodynamics and post-intubation cortisol in the administration of intravenous Magnesium sulfate and intravenous Lidocaine. The study sample was all patients who underwent surgery who met the inclusion and exclusion criteria.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516861
Sponsor's protocol ID
USumateraUtara01
Status last verified
Jul 2024
First submitted
23 Jun 2024
Last updated
24 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bousselmi R, Lebbi MA, Bargaoui A, Ben Romdhane M, Messaoudi A, Ben Gabsia A, Ferjani M. Lidocaine reduces endotracheal tube associated side effects when instilled over the glottis but not when used to inflate the cuff: A double blind, placebo-controlled, randomized trial. Tunis Med. 2014 Jan;92(1):29-33.

    PubMed 24879167

  • Silpa AR, Koshy KA, Subramanian A, Pradeep KK. Comparison of the efficacy of two doses of dexmedetomidine in attenuating the hemodynamic response to intubation in patients undergoing elective cardiac surgery: A randomized double-blinded study. J Anaesthesiol Clin Pharmacol. 2020 Jan-Mar;36(1):83-87. doi: 10.4103/joacp.JOACP_235_18. Epub 2020 Feb 18.

    PubMed 32174664

  • Sriganesh K, Syeda S, Shanthanna H, Venkataramaiah S, Palaniswamy SR. Effect of Opioid Versus Non-Opioid Analgesia on Surgical Pleth Index and Biomarkers of Surgical Stress During Neurosurgery for Brain Tumors: Preliminary Findings. Neurol India. 2020 Sep-Oct;68(5):1101-1105. doi: 10.4103/0028-3886.294559.

    PubMed 33109859

  • Finnerty CC, Mabvuure NT, Ali A, Kozar RA, Herndon DN. The surgically induced stress response. JPEN J Parenter Enteral Nutr. 2013 Sep;37(5 Suppl):21S-9S. doi: 10.1177/0148607113496117.

    PubMed 24009246

  • Rastogi, S., Yadav, S. K., Agarwal, A., Kumar, S., & Malviya, D. (2020). Biochemical markers and haemodynamic changes of stress response after intubation with direct laryngoscopy versus video laryngoscopy versus fiberoptic intubation: A comparative study. Indian Journal of Clinical Anaesthesia, 7(4), 681-686.

  • Prete A, Yan Q, Al-Tarrah K, Akturk HK, Prokop LJ, Alahdab F, Foster MA, Lord JM, Karavitaki N, Wass JA, Murad MH, Arlt W, Bancos I. The cortisol stress response induced by surgery: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2018 Nov;89(5):554-567. doi: 10.1111/cen.13820. Epub 2018 Aug 23.

    PubMed 30047158

  • Gil-Gouveia R, Goadsby PJ. Neuropsychiatric side-effects of lidocaine: examples from the treatment of headache and a review. Cephalalgia. 2009 May;29(5):496-508. doi: 10.1111/j.1468-2982.2008.01800.x. Epub 2009 Feb 24.

    PubMed 19250287

  • Misganaw A, Sitote M, Jemal S, Melese E, Hune M, Seyoum F, Sema A, Bimrew D. Comparison of intravenous magnesium sulphate and lidocaine for attenuation of cardiovascular response to laryngoscopy and endotracheal intubation in elective surgical patients at Zewditu Memorial Hospital Addis Ababa, Ethiopia. PLoS One. 2021 Jun 1;16(6):e0252465. doi: 10.1371/journal.pone.0252465. eCollection 2021.

    PubMed 34061894

  • Mendonca FT, de Queiroz LM, Guimaraes CC, Xavier AC. Effects of lidocaine and magnesium sulfate in attenuating hemodynamic response to tracheal intubation: single-center, prospective, double-blind, randomized study. Braz J Anesthesiol. 2017 Jan-Feb;67(1):50-56. doi: 10.1016/j.bjane.2015.08.004. Epub 2016 Nov 22.

    PubMed 28017170

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Magnesium Sulfate 20 MG/ML, Lidocaine IV and saline solution in people with Intubation Complication, run by Arsil Radiansyah 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 4 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: finished, as of the sponsor's last update on 24 Jul 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Systolic Blood Pressure (time frame: 1 month). 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?

On the ClinicalTrials.gov record for NCT06516861, which also lists 9 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 24 Jul 2024.

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