Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels

NCT06516861 | Completed Phase 1

• 1 other identifier: USumateraUtara01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation Complication

Keywords

Craniotomy; Intubation; Lidocaine; MgSO4

Outcome Measures

Primary Outcomes (4)

• Systolic Blood Pressure

  mmHg

  1 month

• Diastolic Blood Pressure

  mmHg

  1 month

• 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

  1 month

• Heart Rate

  beats per minute

  1 month

Secondary Outcomes (1)

• Cortisol Levels

  1 month

Study Arms (3)

MgSO4 intravenous

EXPERIMENTAL

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

Lidocaine intravenous

EXPERIMENTAL

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

NaCl 0,9% Intravenous

PLACEBO COMPARATOR

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

Magnesium Sulfate 20 MG/ML DRUG

Administered intravenously with a dose of 30 mg/kg

Also known as: Magnesium sulfate injection

MgSO4 intravenous

Lidocaine IV DRUG

Administered intravenously with a dose of 1.5mg/Kg

Also known as: Lidocaine

Lidocaine intravenous

saline solution DRUG

Administered intravenously with 20 ml

Also known as: NaCl 0,9% Solution

NaCl 0,9% Intravenous

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arsil Radiansyah: lead
• Universitas Sumatera Utara: collaborator

Study Sites (1)

Adam Malik General Hospital

Medan, North Sumatra, 20136, Indonesia

Location

Related Publications (9)

• 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.

  PMID: 24879167 RESULT

• 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.

  PMID: 32174664 RESULT

• 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.

  PMID: 33109859 RESULT

• 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.

  PMID: 24009246 RESULT

• 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.

  RESULT

• 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.

  PMID: 30047158 RESULT

• 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.

  PMID: 19250287 RESULT

• 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.

  PMID: 34061894 RESULT

• 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.

  PMID: 28017170 RESULT

MeSH Terms

Interventions

Magnesium Sulfate; Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rr Sinta Irina, MD

  Universitas Sumatera Utara

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: masks the subjects and care provider from knowing which study treatment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Doctor

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 24, 2024
• Study Start: January 31, 2024
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)