Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
NCT Number: NCT06249113
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
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Jakarta Pusat, DKI Jakarta, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NaCl 0.9% continous intravenous on tumor craniotomy surgery
Other names: Normal Saline
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Other names: Lidocaine Intravenous
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
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
Time frame: Intraoperation
Blood Sugar Levels measured by blood test during surgery
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)
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
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
Indonesia University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03486106
Anesthesia; Functional, Surgery
Richmond, Virginia, United States
View Trial DetailsNCT05320718
Anesthesia, Local, Regional Anesthesia
Beijing, Beijing Municipality, China
View Trial DetailsNCT05552092
Surgery
Gwangju, South Korea
View Trial DetailsNCT03369210
Anemia, Hematologic Diseases
Aachen, Germany
View Trial Details