Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery

NCT06249113 | Completed

• 1 other identifier: IndonesiaUAnes1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of adjuvant continuous lidocaine in General Anesthesia on Depth of Anesthesia (qCON), Pain Response (qNOX), and Blood Sugar Levels in Elective Primary Tumor Craniotomy Surgery

Conditions

Surgery; Anesthesia; Functional; Haemodynamic Instability

Keywords

Adjuvant Continuous Lidocaine; General Anesthesia; Depth of Anesthesia; Pain Response; Blood Sugar Levels; Elective Primary Tumor Craniotomy Surgery

Outcome Measures

Primary Outcomes (3)

• Depth of Anaesthesia

  Depth of Anaesthesia measured by qCON index on CONOX monitor. qCON ranges from 0 to 99. A qCON index of more than 60 indicates inadequate use of sedative agents, whereas a qCON of less than 40 indicates excessive sedation

  Intraoperation

• Pain Response

  Pain Response measured by qNOX index on CONOX monitor. The qNOX index uses a scale from 0 to 99 where 99 indicates a high probability of response to noxious stimulation. A decreasing index value means a smaller probability of response to the stimulus

  Intraoperation

• Blood Sugar Levels

  Blood Sugar Levels measured by blood test during surgery

  Intraoperation

Secondary Outcomes (3)

• Blood Pressure

  Intraoperation

• Heart Rate

  Intraoperation

• Body Temperature

  Intraoperation

Study Arms (2)

NaCl 0.9% continous intravenous on tumor craniotomy surgery

PLACEBO COMPARATOR

NaCl 0.9% continous intravenous on general anesthesia during tumor craniotomy surgery

Drug: NaCl 0.9%

Adjuvant lidocaine continous intravenous on tumor craniotomy surgery

ACTIVE COMPARATOR

Adjuvant lidocaine continous intravenous on general anesthesia during tumor craniotomy surgery

Drug: Adjuvant lidocaine continous

Interventions

NaCl 0.9% DRUG

NaCl 0.9% continous intravenous on tumor craniotomy surgery

Also known as: Normal Saline

NaCl 0.9% continous intravenous on tumor craniotomy surgery

Adjuvant lidocaine continous DRUG

Adjuvant lidocaine continous intravenous on tumor craniotomy surgery

Also known as: Lidocaine Intravenous

Adjuvant lidocaine continous intravenous on tumor craniotomy surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 - 65 years with a diagnosis of brain tumor supratentorial who will undergo craniotomy by opening the dura
• ASA physical status 1-3
• Surgery using a head pin
• The level of consciousness was assessed with the Glasgow Coma Scale 15

You may not qualify if:

• The patient's family or guardian refuses informed consent included in the research
• The patient has atrioventricular block
• There is a midline shift \> 5.4 mm
• Diagnosis of glioblastoma multiforme or metastases
• History of allergies to drugs used in the study
• The patient routinely consumes or is administered class of drugs adrenergic agonists or antagonists (e.g., beta blockers, α-2 agonists, vasodilator, vasoconstrictor or inotropic).
• The patient has been regularly consuming analgesic agents for the past 2 weeks.
• The patient has a history of cardiac arrhythmia, kidney or liver disease based on the results of the history and confirmed by further examination.
• Suffering from diabetes mellitus or taking anti-drugs hyperglycemia based on preoperative assessment.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Location

Related Publications (29)

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• Saito J, Masters J, Hirota K, Ma D. Anesthesia and brain tumor surgery: technical considerations based on current research evidence. Curr Opin Anaesthesiol. 2019 Oct;32(5):553-562. doi: 10.1097/ACO.0000000000000749.

  PMID: 31145197 RESULT

Related Links

• Neuro-anesthetic Management of Craniotomy-surgery in Removal Tumor Multiple Meningioma Patients: A Case Report
• Effects of indexes of consciousness (IoC1 and IoC2) monitoring on remifentanil dosage in modified radical mastectomy: a randomized trial
• Acute stress-induced changes in hormone and lipid levels in mouse plasma
• Efek Pemberian Lidokain Intravena Kontinu Intraoperasi terhadap Kebutuhan Isofluran dan Pemakaian Fentanil pada Operasi Dekompresi dan Stabilisasi Posterior Vertebra

MeSH Terms

Interventions

Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Arief Cahyadi, Specialist

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anestesiologist, Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 8, 2024
• Study Start: January 16, 2023
• Primary Completion: November 23, 2023
• Study Completion: January 10, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)