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SurgeryNCT06249113

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

A study testing NaCl 0.9% and Adjuvant lidocaine continous in people with Surgery and Anesthesia; Functional, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
NaCl 0.9% and Adjuvant lidocaine continous
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteIndonesia
Study dates
16 Jan 2023to 10 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Central National Hospital

    Jakarta Pusat, DKI Jakarta

Other trials in Indonesia

About this study

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

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

Read the 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.

Being tested
NaCl 0.9%, Adjuvant lidocaine continous
Keywords
Adjuvant Continuous Lidocaine, General Anesthesia, Depth of Anesthesia, Pain Response, Blood Sugar Levels, Elective Primary Tumor Craniotomy Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NaCl 0.9%Drug

    Also called Normal Saline

    NaCl 0.9% continous intravenous on tumor craniotomy surgery

  • Adjuvant lidocaine continousDrug

    Also called Lidocaine Intravenous

    Adjuvant lidocaine continous intravenous on tumor craniotomy surgery

Study groups in NCT06249113
Study groupRoleWhat they receive
NaCl 0.9% continous intravenous on tumor craniotomy surgeryPlacebo comparatorNaCl 0.9% continous intravenous on general anesthesia during tumor craniotomy surgery
Receives: Drug: NaCl 0.9%
Adjuvant lidocaine continous intravenous on tumor craniotomy surgeryActive comparatorAdjuvant lidocaine continous intravenous on general anesthesia during tumor craniotomy surgery
Receives: Drug: Adjuvant lidocaine continous

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Intraoperation

  2. 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

    Measured: Intraoperation

  3. Blood Sugar Levels

    Blood Sugar Levels measured by blood test during surgery

    Measured: Intraoperation

Secondary outcomes (3)

  1. 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)

    Measured: Intraoperation

  2. 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

    Measured: Intraoperation

  3. 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

    Measured: Intraoperation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start16 Jan 2023
  3. Primary completion23 Nov 2023
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249113
Sponsor's protocol ID
IndonesiaUAnes1001
Status last verified
Feb 2024
First submitted
16 Jan 2024
Last updated
16 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25313193

  • 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.

    PubMed 25478537

  • 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.

    PubMed 28415943

  • 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.

    PubMed 11575527

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

    PubMed 23470218

  • 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.

    PubMed 27285727

  • 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.

    PubMed 30117019

  • 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.

    PubMed 19923506

  • Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.

    PubMed 29864216

  • 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.

    PubMed 26397235

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

    PubMed 31105305

  • Lapointe S, Perry A, Butowski NA. Primary brain tumours in adults. Lancet. 2018 Aug 4;392(10145):432-446. doi: 10.1016/S0140-6736(18)30990-5. Epub 2018 Jul 27.

    PubMed 30060998

  • Kirby S, Purdy RA. Headaches and brain tumors. Neurol Clin. 2014 May;32(2):423-32. doi: 10.1016/j.ncl.2013.11.006. Epub 2013 Dec 27.

    PubMed 24703537

  • Vacas S, Van de Wiele B. Designing a pain management protocol for craniotomy: A narrative review and consideration of promising practices. Surg Neurol Int. 2017 Dec 6;8:291. doi: 10.4103/sni.sni_301_17. eCollection 2017.

    PubMed 29285407

  • 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.

    PubMed 28299313

Questions about this trial

What is this clinical trial studying?

A study testing NaCl 0.9% and Adjuvant lidocaine continous in people with Surgery and Anesthesia; Functional, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depth of Anaesthesia (time frame: Intraoperation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06249113, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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