Ignite Creation Date:
2024-10-25 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521697
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Effects of Minimal-Flow Sevoflurane and Multimodal Analgesia in Head and Neck Cancer Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anesthetic-sparing and Renal Protection Effects of Minimal-flow Sevoflurane Anesthesia and Multimodal Analgesia Using a Mixture of Dexmedetomidine-ketamine-lidocaine in Head and Neck Cancer Patients With Free Flap Microvascular Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the anesthetic-sparing and renal protection effects of minimal-flow sevoflurane anesthesia combined with multimodal analgesia using dexmedetomidine ketamine and lidocaine in head and neck cancer patients undergoing free flap microvascular surgery The 2x2 factorial randomized controlled trial aims to compare sevoflurane usage and renal function changes with different fresh gas flow rates and multimodal analgesia
Detailed Description:
This study investigates the anesthetic-sparing and renal protection effects of minimal-flow sevoflurane anesthesia combined with a multimodal analgesia strategy using dexmedetomidine ketamine and lidocaine in head and neck cancer patients undergoing free flap microvascular surgery The trial employs a 2x2 factorial randomized controlled design to evaluate the effectiveness of different fresh gas flow rates and multimodal analgesia on sevoflurane usage and renal function
Background and Significance
Sevoflurane a widely used anesthetic for prolonged surgeries significantly contributes to healthcare-related greenhouse gas emissions Reducing fresh gas flow during anesthesia effectively minimizes anesthetic usage but concerns about potential renal damage hinder its clinical application Recent studies show that sevoflurane enhances renal sympathetic nerve activity leading to decreased renal blood flow and increased risks of acute kidney injury particularly when coupled with factors like low blood pressure
Multi-modal analgesia combining drugs like dexmedetomidine ketamine and lidocaine has emerged as a trend in anesthesiology These drugs not only reduce sevoflurane usage but may also counteract its renal effects This project aims to investigate the renal protective effects and anesthetic reduction potential of a multi-modal analgesia strategy in head and neck cancer surgeries
Study Objectives
To evaluate the anesthetic-sparing effect of minimal-flow sevoflurane anesthesia 05 Lmin combined with dexmedetomidine-ketamine-lidocaine multimodal analgesia
To assess the renal protection effects of dexmedetomidine-ketamine-lidocaine multimodal analgesia during minimal-flow sevoflurane anesthesia
To examine the safety and other potential effects eg hemodynamic stability postoperative cognitive function of the combined anesthesia strategy
Methods
The study will be conducted at National Taiwan University Hospital and will involve adult patients 18-99 years scheduled for head and neck cancer tumor resection and free flap reconstruction surgery Patients will be randomized into four groups in a 2x2 factorial design
Group 1 HL D Fresh gas flow at 05 Lmin with dexmedetomidine-ketamine-lidocaine mixture
Group 2 HL Fresh gas flow at 05 Lmin with normal saline Group 3 D Fresh gas flow at 10 Lmin with dexmedetomidine-ketamine-lidocaine mixture
Group 4 Control Fresh gas flow at 10 Lmin with normal saline The dexmedetomidine-ketamine-lidocaine mixture will be continuously infused from the induction of anesthesia until the end of surgery Fresh gas flow settings will be maintained using the EtControl function of the GE Aisys CS2 anesthesia machine Anesthetic depth and hemodynamic parameters will be monitored throughout the procedure
Data Collection
Primary Outcome Measures Sevoflurane usage mLh and changes in renal function serum renin AVP levels urine KIM-1 NGAL levels
Secondary Outcome Measures Incidence of acute kidney injury hemodynamic stability postoperative pain scores length of hospital stay and postoperative cognitive function
Blood and urine samples will be collected at four time points before anesthesia induction upon arrival in the ICU 24 hours post-surgery and 48 hours post-surgery Clinical data including demographic information surgical details anesthetic drug usage hemodynamic parameters and postoperative outcomes will also be recorded
Statistical Analysis
Data will be analyzed using appropriate statistical methods including Students t-test Mann-Whitney U test Chi-square test Fishers exact test and multivariate analysis of variance MANOVA Statistical significance will be defined as p 005
Potential Challenges and Solutions
Potential challenges include patient recruitment and adherence to protocol To mitigate these the study will involve experienced anesthesiologists and research staff who will ensure proper patient selection and protocol compliance
Expected Outcomes
The study aims to propose a feasible strategy to mitigate sevofluranes renal effects crucial for patients at risk of acute kidney injury It also seeks to validate that minimal fresh gas flow 05 Lmin during sevoflurane anesthesia coupled with multimodal analgesia reduces sevoflurane usage saving costs and contributing to carbon reduction Additionally the study will explore the potential protective effects of the multimodal analgesia strategy on other organs during prolonged surgeries
Background and Significance
Sevoflurane a widely used anesthetic for prolonged surgeries significantly contributes to healthcare-related greenhouse gas emissions Reducing fresh gas flow during anesthesia effectively minimizes anesthetic usage but concerns about potential renal damage hinder its clinical application Recent studies show that sevoflurane enhances renal sympathetic nerve activity leading to decreased renal blood flow and increased risks of acute kidney injury particularly when coupled with factors like low blood pressure
Multi-modal analgesia combining drugs like dexmedetomidine ketamine and lidocaine has emerged as a trend in anesthesiology These drugs not only reduce sevoflurane usage but may also counteract its renal effects This project aims to investigate the renal protective effects and anesthetic reduction potential of a multi-modal analgesia strategy in head and neck cancer surgeries
Study Objectives
To evaluate the anesthetic-sparing effect of minimal-flow sevoflurane anesthesia 05 Lmin combined with dexmedetomidine-ketamine-lidocaine multimodal analgesia
To assess the renal protection effects of dexmedetomidine-ketamine-lidocaine multimodal analgesia during minimal-flow sevoflurane anesthesia
To examine the safety and other potential effects eg hemodynamic stability postoperative cognitive function of the combined anesthesia strategy
Methods
The study will be conducted at National Taiwan University Hospital and will involve adult patients 18-99 years scheduled for head and neck cancer tumor resection and free flap reconstruction surgery Patients will be randomized into four groups in a 2x2 factorial design
Group 1 HL D Fresh gas flow at 05 Lmin with dexmedetomidine-ketamine-lidocaine mixture
Group 2 HL Fresh gas flow at 05 Lmin with normal saline Group 3 D Fresh gas flow at 10 Lmin with dexmedetomidine-ketamine-lidocaine mixture
Group 4 Control Fresh gas flow at 10 Lmin with normal saline The dexmedetomidine-ketamine-lidocaine mixture will be continuously infused from the induction of anesthesia until the end of surgery Fresh gas flow settings will be maintained using the EtControl function of the GE Aisys CS2 anesthesia machine Anesthetic depth and hemodynamic parameters will be monitored throughout the procedure
Data Collection
Primary Outcome Measures Sevoflurane usage mLh and changes in renal function serum renin AVP levels urine KIM-1 NGAL levels
Secondary Outcome Measures Incidence of acute kidney injury hemodynamic stability postoperative pain scores length of hospital stay and postoperative cognitive function
Blood and urine samples will be collected at four time points before anesthesia induction upon arrival in the ICU 24 hours post-surgery and 48 hours post-surgery Clinical data including demographic information surgical details anesthetic drug usage hemodynamic parameters and postoperative outcomes will also be recorded
Statistical Analysis
Data will be analyzed using appropriate statistical methods including Students t-test Mann-Whitney U test Chi-square test Fishers exact test and multivariate analysis of variance MANOVA Statistical significance will be defined as p 005
Potential Challenges and Solutions
Potential challenges include patient recruitment and adherence to protocol To mitigate these the study will involve experienced anesthesiologists and research staff who will ensure proper patient selection and protocol compliance
Expected Outcomes
The study aims to propose a feasible strategy to mitigate sevofluranes renal effects crucial for patients at risk of acute kidney injury It also seeks to validate that minimal fresh gas flow 05 Lmin during sevoflurane anesthesia coupled with multimodal analgesia reduces sevoflurane usage saving costs and contributing to carbon reduction Additionally the study will explore the potential protective effects of the multimodal analgesia strategy on other organs during prolonged surgeries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None