Clinical trial

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

Name
IndonesiaUAnes1001
Description
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
Trial arms
Trial start
2023-01-16
Estimated PCD
2023-11-23
Trial end
2024-01-10
Status
Completed
Treatment
NaCl 0.9%
NaCl 0.9% continous intravenous on tumor craniotomy surgery
Arms:
NaCl 0.9% continous intravenous on tumor craniotomy surgery
Other names:
Normal Saline
Adjuvant lidocaine continous
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Arms:
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Other names:
Lidocaine Intravenous
Size
60
Primary endpoint
Depth of Anaesthesia
Intraoperation
Pain Response
Intraoperation
Blood Sugar Levels
Intraoperation
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-02-16

1 organization

2 products

3 indications

Product
NaCl
Indication
Surgery
Indication
Anesthesia