Comparing recovery speeds from anesthesia in 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
NA · Clinical Hospital Centre Zagreb · NCT06275087
This study is testing whether two different types of anesthesia used during mouth surgery help patients recover faster and feel better afterward.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Hospital Centre Zagreb (other) |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT06275087 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the recovery speed and quality of patients undergoing intraoral surgery under two different anesthesia methods: Total Intravenous Anesthesia (TIVA) with propofol and inhalational anesthesia with sevoflurane. Participants will complete a questionnaire assessing their recovery quality at various time points post-anesthesia, and their muscle strength will be evaluated through grip and bite strength tests. The study will analyze differences in recovery speed, muscle strength recovery, and postoperative symptoms between the two anesthesia groups.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with ASA status 1-2 requiring intraoral surgical procedures lasting more than 30 minutes.
Not a fit: Patients with ASA status 3 or higher, those requiring ICU care, or those undergoing specific surgical procedures that may affect muscle strength will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery protocols for patients undergoing intraoral surgeries, enhancing their postoperative experience.
How similar studies have performed: Previous studies have shown varying results with different anesthesia methods, but this specific comparison of TIVA and inhalational anesthesia in intraoral surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 The exclusion criteria are: * 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
Where this trial is running
Zagreb
- University Hospital Centre Zagreb — Zagreb, Croatia (RECRUITING)
Study contacts
- Principal investigator: Ivan Šitum, MD — UHC Zagreb
- Study coordinator: Ivan Šitum, MD
- Email: ivsitum@gmail.com
- Phone: 0915143620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intraoral Tumor, TIVA, Propofol, Intraoral surgery, Postoperative recovery, recovery of muscle strenght