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

February 15, 2024 updated by: Arief Cahyadi, Indonesia University

Effectiveness 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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Craniotomy for resection of brain tumors is frequently performed in neurosurgical practice. Craniotomy surgery is currently starting to use the Enhanced Recovery After Surgery (ERAS) protocol, namely for intraoperative pain management. Intraoperative pain can be evaluated through intraoperative hemodynamic conditions or can also use qCON and qNOX parameters and blood sugar levels. Perioperative pain management in the form of continuous intravenous lidocaine shows a role in reducing intraoperative pain. However, the use of intravenous lidocaine in ERAS protocols is still debated. So this study aims to use general anesthesia with continuous IV lidocaine adjuvant general anesthesia to affect depth of anesthesia (qCONtm) and intraoperative pain response in the form of values (qNOXtm), and blood sugar levels during elective primary tumor craniotomy.

The method is a Double-Blinded Randomized Control Trial. 60 patients aged 18-65 years who were diagnosed with craniotomy supratentorial tumor were randomly allocated to either Adjuvant Continuous Lidocaine (intervention group) or Normal Saline 0.9% (control group). Both drugs are given in a 20 ml syringe. The primary outcome measure of the study was the intraoperative of qCON, qNOX, and Blood Sugar. While the secondary outcome was the intraoperative hemodynamic.

All patients will be induced by general anesthesia using fentanyl 3 μg/kg IV as coinduction and propofol 1 mg/kg until the patient falls asleep. After induction, patients who receive lidocaine will receive a continuous intravenous infusion of 2 mg/kg/hour of lidocaine while other patients are given 0.9% NaCl as control. All patients data of hemodynamics, qCon, QNox, and blood glucose recorded and will be analyze.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. The patient's family or guardian refuses informed consent included in the research
  2. The patient has atrioventricular block
  3. There is a midline shift > 5.4 mm
  4. Diagnosis of glioblastoma multiforme or metastases
  5. History of allergies to drugs used in the study
  6. 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).
  7. The patient has been regularly consuming analgesic agents for the past 2 weeks.
  8. The patient has a history of cardiac arrhythmia, kidney or liver disease based on the results of the history and confirmed by further examination.
  9. Suffering from diabetes mellitus or taking anti-drugs hyperglycemia based on preoperative assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: NaCl 0.9% continous intravenous on tumor craniotomy surgery
NaCl 0.9% continous intravenous on general anesthesia during tumor craniotomy surgery
Drug: NaCl 0.9%
NaCl 0.9% continous intravenous on tumor craniotomy surgery
Other Names:
  • Normal Saline
Active Comparator: Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Adjuvant lidocaine continous intravenous on general anesthesia during tumor craniotomy surgery
Drug: Adjuvant lidocaine continous
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Other Names:
  • Lidocaine Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Sugar Levels
Time Frame: Intraoperation
Blood Sugar Levels measured by blood test during surgery
Intraoperation
Depth of Anaesthesia
Time Frame: Intraoperation
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
Time Frame: Intraoperation
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: Intraoperation
Heart Rate (times/minutes) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing
Intraoperation
Body Temperature
Time Frame: Intraoperation
Body Temperature (celsius) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing
Intraoperation
Blood Pressure
Time Frame: Intraoperation
blood pressure (mm/Hg) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing. Blood Preasure includes systolic (mmHg), Diastolic (mmHg), and Mean Arterial Pressure (mmHg)
Intraoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Arief Cahyadi, Specialist, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2023

Primary Completion (Actual)

November 23, 2023

Study Completion (Actual)

January 10, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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