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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249113
• Other study ID #: IndonesiaUAnes1001
• Status: Completed
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: February 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2024
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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, a-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.

Related Conditions & MeSH terms

• Anesthesia; Functional
• Haemodynamic Instability
• Surgery

Intervention

Drug:
• NaCl 0.9%
NaCl 0.9% continous intravenous on tumor craniotomy surgery
• Adjuvant lidocaine continous
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (29)

Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x. — View Citation

Can BO, Bilgin H. Effects of scalp block with bupivacaine versus levobupivacaine on haemodynamic response to head pinning and comparative efficacies in postoperative analgesia: A randomized controlled trial. J Int Med Res. 2017 Apr;45(2):439-450. doi: 10.1177/0300060516665752. Epub 2017 Mar 7. — View Citation

Chowdhury T, Garg R, Sheshadri V, Venkatraghavan L, Bergese SD, Cappellani RB, Schaller B. Perioperative Factors Contributing the Post-Craniotomy Pain: A Synthesis of Concepts. Front Med (Lausanne). 2017 Mar 1;4:23. doi: 10.3389/fmed.2017.00023. eCollection 2017. — View Citation

Christenson C, Martinez-Vazquez P, Breidenstein M, Farhang B, Mathews J, Melia U, Jensen EW, Mathews D. Comparison of the Conox (qCON) and Sedline (PSI) depth of anaesthesia indices to predict the hypnotic effect during desflurane general anaesthesia with ketamine. J Clin Monit Comput. 2021 Dec;35(6):1421-1428. doi: 10.1007/s10877-020-00619-3. Epub 2020 Nov 19. — View Citation

Dashti M, Amini S, Azarfarin R, Totonchi Z, Hatami M. Hemodynamic changes following endotracheal intubation with glidescope((R)) video-laryngoscope in patients with untreated hypertension. Res Cardiovasc Med. 2014 May;3(2):e17598. doi: 10.5812/cardiovascmed.17598. Epub 2014 Apr 1. — View Citation

de Robles P, Fiest KM, Frolkis AD, Pringsheim T, Atta C, St Germaine-Smith C, Day L, Lam D, Jette N. The worldwide incidence and prevalence of primary brain tumors: a systematic review and meta-analysis. Neuro Oncol. 2015 Jun;17(6):776-83. doi: 10.1093/neuonc/nou283. Epub 2014 Oct 13. — View Citation

DeVon HA, Piano MR, Rosenfeld AG, Hoppensteadt DA. The association of pain with protein inflammatory biomarkers: a review of the literature. Nurs Res. 2014 Jan-Feb;63(1):51-62. doi: 10.1097/NNR.0000000000000013. — View Citation

Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available. — View Citation

Gaughen CM, Durieux M. The effect of too much intravenous lidocaine on bispectral index. Anesth Analg. 2006 Dec;103(6):1464-5. doi: 10.1213/01.ane.0000247700.71278.70. — View Citation

Greisen J, Juhl CB, Grofte T, Vilstrup H, Jensen TS, Schmitz O. Acute pain induces insulin resistance in humans. Anesthesiology. 2001 Sep;95(3):578-84. doi: 10.1097/00000542-200109000-00007. — View Citation

Gruenbaum SE, Meng L, Bilotta F. Recent trends in the anesthetic management of craniotomy for supratentorial tumor resection. Curr Opin Anaesthesiol. 2016 Oct;29(5):552-7. doi: 10.1097/ACO.0000000000000365. — View Citation

Hani U, Bakhshi SK, Shamim MS. Enhanced Recovery after Elective Craniotomy for Brain Tumours. J Pak Med Assoc. 2019 May;69(5):749-751. — View Citation

Hermanns H, Hollmann MW, Stevens MF, Lirk P, Brandenburger T, Piegeler T, Werdehausen R. Molecular mechanisms of action of systemic lidocaine in acute and chronic pain: a narrative review. Br J Anaesth. 2019 Sep;123(3):335-349. doi: 10.1016/j.bja.2019.06.014. Epub 2019 Jul 11. — View Citation

Jensen EW, Valencia JF, Lopez A, Anglada T, Agusti M, Ramos Y, Serra R, Jospin M, Pineda P, Gambus P. Monitoring hypnotic effect and nociception with two EEG-derived indices, qCON and qNOX, during general anaesthesia. Acta Anaesthesiol Scand. 2014 Sep;58(8):933-41. doi: 10.1111/aas.12359. Epub 2014 Jul 4. — View Citation

Jensen EW. New findings and trends for depth of anesthesia monitoring. Korean J Anesthesiol. 2018 Oct;71(5):343-344. doi: 10.4097/kja.d.18.00277. Epub 2018 Oct 1. No abstract available. — View Citation

Kandil E, Melikman E, Adinoff B. Lidocaine Infusion: A Promising Therapeutic Approach for Chronic Pain. J Anesth Clin Res. 2017 Jan;8(1):697. doi: 10.4172/2155-6148.1000697. Epub 2017 Jan 11. — View Citation

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Marik PE, Bellomo R. Stress hyperglycemia: an essential survival response! Crit Care. 2013 Mar 6;17(2):305. doi: 10.1186/cc12514. — View Citation

McKay A, Gottschalk A, Ploppa A, Durieux ME, Groves DS. Systemic lidocaine decreased the perioperative opioid analgesic requirements but failed to reduce discharge time after ambulatory surgery. Anesth Analg. 2009 Dec;109(6):1805-8. doi: 10.1213/ANE.0b013e3181be371b. — View Citation

Melia U, Gabarron E, Agusti M, Souto N, Pineda P, Fontanet J, Vallverdu M, Jensen EW, Gambus P. Comparison of the qCON and qNOX indices for the assessment of unconsciousness level and noxious stimulation response during surgery. J Clin Monit Comput. 2017 Dec;31(6):1273-1281. doi: 10.1007/s10877-016-9948-z. Epub 2016 Oct 20. — View Citation

Muller JN, Kreuzer M, Garcia PS, Schneider G, Hautmann H. Monitoring depth of sedation: evaluating the agreement between the Bispectral Index, qCON and the Entropy Module's State Entropy during flexible bronchoscopy. Minerva Anestesiol. 2017 Jun;83(6):563-573. doi: 10.23736/S0375-9393.17.11262-9. Epub 2017 Feb 8. — View Citation

Nakhli MS, Kahloul M, Guizani T, Zedini C, Chaouch A, Naija W. Intravenous lidocaine as adjuvant to general anesthesia in renal surgery. Libyan J Med. 2018 Dec;13(1):1433418. doi: 10.1080/19932820.2018.1433418. — View Citation

Peng Y, Zhang W, Kass IS, Han R. Lidocaine Reduces Acute Postoperative Pain After Supratentorial Tumor Surgery in the PACU: A Secondary Finding From a Randomized, Controlled Trial. J Neurosurg Anesthesiol. 2016 Oct;28(4):309-15. doi: 10.1097/ANA.0000000000000230. — View Citation

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. — View Citation

Soleimanpour H, Hassanzadeh K, Vaezi H, Golzari SE, Esfanjani RM, Soleimanpour M. Effectiveness of intravenous lidocaine versus intravenous morphine for patients with renal colic in the emergency department. BMC Urol. 2012 May 4;12:13. doi: 10.1186/1471-2490-12-13. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Blood Sugar Levels	Blood Sugar Levels measured by blood test during surgery	Intraoperation
Secondary	Blood Pressure	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
Secondary	Heart Rate	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
Secondary	Body Temperature	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

External Links

•   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
•   Effects of indexes of consciousness (IoC1 and IoC2) monitoring on remifentanil dosage in modified radical mastectomy: a randomized trial
•   Neuro-anesthetic Management of Craniotomy-surgery in Removal Tumor Multiple Meningioma Patients: A Case Report