RecruitingNot ApplicableNCT06275087

Differences in Speed of Recovery From Anesthesia for Intraoral Surgery

Differences in Speed of Recovery From Anesthesia and Recovery of Muscle Strength in General Balanced Inhalation Anesthesia and Total Intravenous Anesthesia for Intraoral Surgery - Clinical Randomised Trial


Sponsor

Clinical Hospital Centre Zagreb

Enrollment

42 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare two groups of patients going in general anesthesia for intraoral surgery, the first group TIVA with propofol and the second group inhalational with sevoflurane. The main questions it aims to answer are to asses speed and quality of recovery from general anesthesia. Participants will fill out a questionnaire to evaluate the quality of recovery from anesthesia using the QoR-40 1h, 24h, and 30 days after waking up from anesthesia in comparison to the results of the same questionnaire before surgery. Also, the investigators will perform a hand grip and bite strength test on the patients after waking up from anesthesia in the operating room, after 1 hour in the recovery room, and after 24 hours compared to preoperative values. The investigators will compare TIVA and Volatile groups to see if there are any differences in recovery seed, muscle strength recovery, postoperative nausea and vomiting, and shivering between groups.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Criteria for patient inclusion are:
  • patients older than 18 years
  • ASA status 1-2,
  • Patients who have an indication for an intraoral surgical procedure longer than 30 minutes.
  • Surgical interventions on the soft tissues of the mouth, intraoral excision of tumors, operated through the transoral route
  • Patients who agreed to the research and signed the consent

Exclusion Criteria9

  • ASA status 3 and higher,
  • The need for postoperative care in the ICU,
  • Surgery lasting more than 2 hours,
  • Surgical procedures that in the operative plan include injuries to the grip of the masticatory muscles, the masticatory muscles themselves, and procedures on the bone, and thus may result in a difference in the strength of the bite. Masticatory muscles are defined as musculus pterygoideus lateralis, musculus pterygoideus medialis, musculus temporalis and musculus masseter.
  • Surgical procedures on the bone where the bite force test alone could cause injury
  • Patients with diseases of the neuromuscular junction and muscle diseases, myopathy, dystrophy
  • Patients taking medications that can cause myopathy or muscle weakness
  • Known allergies to drugs used in the trial,
  • Refusing to participate

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Interventions

DRUGPropofol

The experimental group will not receive volatile anesthetic, instead, they will receive propofol infusion

DRUGSevoflurane

The control group will not receive TIVA, instead, they will receive sevoflurane via inhalation


Locations(1)

University Hospital Centre Zagreb

Zagreb, Croatia

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NCT06275087