Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249113
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2024-01-16
Brief Title:
Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 09 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 μgkg IV as coinduction and propofol 1 mgkg until the patient falls asleep After induction patients who receive lidocaine will receive a continuous intravenous infusion of 2 mgkghour of lidocaine while other patients are given 09 NaCl as control All patients data of hemodynamics qCon QNox and blood glucose recorded and will be analyze
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 09 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 μgkg IV as coinduction and propofol 1 mgkg until the patient falls asleep After induction patients who receive lidocaine will receive a continuous intravenous infusion of 2 mgkghour of lidocaine while other patients are given 09 NaCl as control All patients data of hemodynamics qCon QNox and blood glucose recorded and will be analyze
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None