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CompletedNCT06516861Updated Jul 24, 2024

Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels

A Phase 1 interventional study of Magnesium Sulfate 20 MG/ML and Lidocaine IV in Intubation Complication, sponsored by Arsil Radiansyah. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Arsil Radiansyah · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2024, registered Jun 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Intubation Complication

Keywords

  • Craniotomy
  • Intubation
  • Lidocaine
  • MgSO4
03

In context

Lead sponsor

This is the only study on the registry with Arsil Radiansyah as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    MgSO4 intravenous

    Sample will be given MgSO4 30mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery

    Drug: Magnesium Sulfate 20 MG/ML

  • Experimental
    Lidocaine intravenous

    Sample will be given Lidocain 1.5mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery

    Drug: Lidocaine IV

  • Placebo comparator
    NaCl 0,9% Intravenous

    Sample will be given NaCl 0,9% Intravenous 20 ml as a premedication drugs before intubation for all patients who had craniotomy surgery

    Drug: saline solution

Interventions

  • DrugMagnesium Sulfate 20 MG/ML

    Administered intravenously with a dose of 30 mg/kg

    Also known as: Magnesium sulfate injection

  • DrugLidocaine IV

    Administered intravenously with a dose of 1.5mg/Kg

    Also known as: Lidocaine

  • Drugsaline solution

    Administered intravenously with 20 ml

    Also known as: NaCl 0,9% Solution

06

What researchers measure

Primary outcomes

  1. Systolic Blood Pressure

    mmHg

    Time frame: 1 month

  2. Diastolic Blood Pressure

    mmHg

    Time frame: 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

    Time frame: 1 month

  4. Heart Rate

    beats per minute

    Time frame: 1 month

Secondary outcomes

  1. Cortisol Levels

    Cortisol Levels in nmol/L

    Time frame: 1 month

07

Study locations

1 site
  • Adam Malik General Hospital
    Medan, Sumatera Utara 20136, Indonesia
08

References and documents

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 ↗

Study documents

  • Study protocol · Jan 8, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06516861
Lead sponsor
Arsil Radiansyah
Collaborators
Universitas Sumatera Utara
Responsible party
Arsil Radiansyah (Resident Doctor, Universitas Sumatera Utara) — Sponsor-investigator
First posted
Jul 24, 2024
Start date
Jan 31, 2024
Primary completion
Feb 1, 2024
Completion
Mar 1, 2024
Last update
Jul 24, 2024

Study contacts

Rr Sinta Irina, MD
study chair · Universitas Sumatera Utara

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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