Effects of Minimal-Flow Sevoflurane and Multimodal Analgesia in Head and Neck Cancer Surgery

NCT06521697 | Not Yet Recruiting Phase 4

• 1 other identifier: 202403100MIND
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer; Anesthesia; Renal Protection; Acute Kidney Injury; Multimodal Analgesia

Keywords

Greenhouse gas; Carbon emissions; Acute kidney injury; Multimodal analgesia; Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• Sevoflurane usage (mL/h)

  Volatile anesthetic consumption hourly

  Intraoperative period

• Renal function

  Changes in renal function (serum renin, AVP levels, urine KIM-1, NGAL levels)

  Perioperative period

Secondary Outcomes (8)

• Acute kidney injury

  Perioperative period

• Hemodynamic stability_1

  Intraoperative period

• Hemodynamic stability_2

  Intraoperative period

• Hemodynamic stability_3

  Intraoperative period

• Postoperative analgesic effect_1

  Perioperative period

Study Arms (4)

Group 1 (HL-D)

EXPERIMENTAL

Fresh gas flow at 0.5 L/min with dexmedetomidine-ketamine-lidocaine mixture

Drug: Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture; Device: Minimal flow sevoflurane

Group 2 (HL-ND)

EXPERIMENTAL

Fresh gas flow at 0.5 L/min with placebo normal saline

Device: Minimal flow sevoflurane

Group 3 (L-D)

EXPERIMENTAL

Fresh gas flow at 1.0 L/min with dexmedetomidine-ketamine-lidocaine mixture

Drug: Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture

Group 4 (L-ND)

NO INTERVENTION

Fresh gas flow at 1.0 L/min with placebo normal saline

Interventions

Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture DRUG

Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture vs placebo normal saline

Also known as: Multimodal analgesia

Group 1 (HL-D); Group 3 (L-D)

Minimal flow sevoflurane DEVICE

Minimal flow sevoflurane anesthesia (0.5 L/min) vs low flow sevoflurane (1 L/min)

Group 1 (HL-D); Group 2 (HL-ND)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-99 years
• Scheduled for head and neck cancer tumor resection and free flap reconstruction surgery

You may not qualify if:

• Preoperative tracheostomy
• History of previous head and neck cancer tumor resection
• Anemia (hematocrit \<30% or recent transfusion)
• Hypertension on ACEI/ARB medications
• Significant medical conditions (e.g., NYHA class 3 or 4 heart failure, eGFR \<60 ml/min/1.73 m², Child B or C liver failure, severe respiratory disorders, pre-existing cognitive impairment)
• ASA physical status 4 or 5
• Allergies to sevoflurane, dexmedetomidine, ketamine, or lidocaine

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ming-Hui Hung, MD

  National Taiwan University Hosital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Hui Hung, MD

CONTACT

+886-972653392; hung.minghui@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employs a triple-blinding approach to ensure unbiased results. The participants, care providers (including anesthesiologists and nurses), and investigators are all blinded to the group assignments. Randomization envelopes containing the treatment allocation will be prepared and sealed by a research assistant who is not involved in patient care or data collection. At the time of surgery, the envelope will be opened by a designated anesthesia nurse who will prepare the study medication (either the dexmedetomidine-ketamine-lidocaine mixture or normal saline) according to the randomization. The medication will be labeled identically to maintain blinding and administered via continuous infusion during anesthesia. Fresh gas flow settings will be adjusted according to the randomization and indicated by a concealed flow meter display.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-center, prospective, 2x2 factorial randomized controlled trial designed to evaluate the anesthetic-sparing and renal protection effects of minimal-flow (intervention 1) sevoflurane anesthesia combined with multimodal analgesia (intervention 2) in head and neck cancer patients undergoing free flap microvascular surgery. Participants will be randomly assigned to one of four groups: Fresh gas flow at 0.5 L/min with dexmedetomidine-ketamine-lidocaine mixture. Fresh gas flow at 0.5 L/min with normal saline. Fresh gas flow at 1.0 L/min with dexmedetomidine-ketamine-lidocaine mixture. Fresh gas flow at 1.0 L/min with normal saline. The study uses triple blinding (participant, care provider, investigator) to ensure unbiased results. The primary purpose of the study is treatment, aiming to reduce anesthetic usage and assess renal protection.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07