Intraoral TumorPSIOSNCT06275087
Differences in Speed of Recovery From Anesthesia for Intraoral Surgery
A study testing Propofol and Sevoflurane in people with Intraoral Tumor, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoral Tumor
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 10 Apr 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
After obtaining the approval of the ethics committee of KBC Zagreb and the Faculty of Dentistry of the University of Zagreb, the research will be conducted at KBC Zagreb.
Criteria for patient inclusion are:
- patients older than 18 years
- ASA status 1-2,
- Patients who have an indication for an intraoral surgical procedure (intraoral tumor excisions) longer than 30 minutes.
- patients who agreed to the research and signed the consent
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
Participants will be randomly divided (1:1 randomisation) according to a predetermined randomization table (32) into the TIVA group and the Volatile group. After identification of the participants in the operating room, participants will be fitted with a peripheral venous line, electrocardiogram monitoring, non-invasive blood pressure measurement, pulse oximeter, capnograph, temperature probe, and bispectral index (BIS) of the electroencephalogram and neuromuscular monitoring, kinemiography with train-of-four (TOF , M-NMT, Drägerwerk AG \& Co. KGaA,) by recording the responses.
The initial anesthesiological induction procedure will not differ in both groups of patients. The drugs that will be used are sufentanil 0.3mcg/kg, propofol 2mg/kg, and cisatracurium 0.1mg/kg.
Participants will be intubated with an endotracheal tube and mechanically ventilated with a mixture of oxygen and air (inspiratory fraction of oxygen 40%) with a total flow of gas mixture of 3 L/min.
Anesthesia will be maintained in the volatile group with the inhaled anesthetic sevoflurane and single doses of cisatracurium. Cisatracurium will be repeated when the TOF ratio is greater than 5%, and the repeat dose will be 0.01 mg/kg. The depth of anesthesia will be controlled by BIS, maintaining values between 25 and 50. Recommended drug doses will be guided by TOF and BIS values.
In the TIVA group, anesthesia will be maintained with a continuous infusion of propofol (5-10 mg/kg/h) and single doses of cisatracurium. Cisatracurium will be repeated when the TOF ratio is greater than 5%, and the repeat dose will be 0.01 mg/kg. The depth of anesthesia will be controlled by BIS, maintaining values between 25 and 50. Recommended drug doses will be guided by TOF and BIS values.
At the end of the surgical intervention in both groups, the neuromuscular block will be antagonized with prostigmine (0.05 mg/kg) along with atropine (0.01 mg/kg) as soon as the patient begins to breathe spontaneously. Patients will then be extubated when the TOF index is greater than 90%
Muscle strength of all participants will be measured with a JAMAR hand dynamometer, and bite force with a gnathodynamometer (Bite force sensor, Monad electronics) in four time intervals:
- Before introduction to anesthesia
- After waking up from anesthesia in the operating room
- 1 hour after waking up from anesthesia in the recovery room
- After 24 hours from the operation
All patients will fill out the Quality of recovery-40 (Qor-40) questionnaire for assessing the quality of recovery after anesthesia and surgery in four time intervals:
- Before introduction to anesthesia
- 1 hour after waking up from anesthesia in the recovery room
- After 24 hours from the operation
- After 30 days from the operation Consent for the use of the QoR-40 questionnaire was obtained by the main researcher from the author, Professor P.S. Myles, and Dr. M. Miklić Bublić, who translated the questionnaire into Croatian.
Postoperative nausea and vomiting and postoperative shivering will also be recorded, as a binary outcome (yes/no), by visual assessment and interaction with the patient.
The time from the end of the operation to waking up will be monitored. Pain will also be recorded based on QoR40 and the visual analogue scale (VAS-scale) for pain assessment. The patient's chronic therapy is recorded, as is the need for postoperative analgesia.
Assuming medium to large effect size, test power of 80% and use of independent t-test for the primary objective and x2 test for the secondary objective with a statistical significance of 0.05, it is necessary to take a sample of 42 patients, 21 subjects per group. . The test for power calculation is G Power Version 3.1.9.6 (46). Assuming that part of the respondents will not be able to follow up until the end of the research, a sample of 50 patients will be taken, that is, 25 patients in each group. A review of similar studies confirmed the sample size (18,47,48). The results will be processed with IBM SPSS statistics v27. For scalar parametric data, the independent Student t test will be used, for non-parametric data, the Mann-Whitney U test, while categorical data will be processed with the Pearson χ² test. One interim analysis for feasibility and precision estimation is planned.
- Conditions
- Intraoral Tumor
- Being tested
- Propofol, Sevoflurane
- Keywords
- TIVA, Propofol, Intraoral surgery, Postoperative recovery, recovery of muscle strenght
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called TIVA
The experimental group will not receive volatile anesthetic, instead, they will receive propofol infusion
SevofluraneDrug
Also called general volatile anesthesia
The control group will not receive TIVA, instead, they will receive sevoflurane via inhalation
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Experimental | The study involves patients in an operating room undergoing standard procedures. The induction procedure for anesthesia is the same for both groups, using sufentanil, propofol, and cisatracurium.
In the TIVA group, anesthesia is maintained with continuous propofol infusion and intermittent cisatracurium doses, guided by neuromuscular and electroencephalogram monitoring. At the end of surgery, neuromuscular block is reversed, and extubation occurs when the train-of-four (TOF) index is over 90%.
Muscle strength and bite force are measured at different intervals before and after anesthesia, using specific instruments. Additionally, patients fill out the Quality of recovery-40 (Qor-40) questionnaire at various time points to assess the quality of recovery after surgery and anesthesia. Receives: Drug: Propofol |
| Volatile group | Active comparator | In the volatile group, anesthesia is maintained with inhaled sevoflurane and intermittent cisatracurium doses. Cisatracurium is repeated based on TOF ratio, and anesthesia depth is controlled by BIS, maintaining values between 25 and 50. Drug doses are adjusted according to TOF and BIS values. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Quality of recovery from anesthesia" QoR-40 questionnaire
The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). The total score and subscales of the QoR-40 are measured using a five-point Likert scale (for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed) and individual scores are then added together, with the minimum score being 40 points and the maximum score being 200 points. The QoR-40 was specifically designed to measure a patient's health status after surgery and anesthesia, and its completion time generally ranges from three to 10 min. The Japanese version of the QoR-40 was also validated according to standard methods of cultural adaptation and psychometric analysis in 2011.
Measured: 1 hour, 24 hour, 30 day
Secondary outcomes (3)
bite strength and hand grip strength
Hand-grip muscle strength and bite strength will be measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.
Measured: after waking in OR up to 10 min, 1 hour after waking, 24 hour after waking
Postoperative nausea and vomiting
determine the difference in the frequency of postoperative nausea and vomiting
Measured: 24 hours
Postoperative shivering
determine the difference in the frequency of postoperative shivering
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start10 Apr 2024
- Primary completion5 Nov 2025
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Intraoral TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Šitum, MD, Clinical Hospital Centre Zagreb
- Investigators
- Ivan Šitum, MD, Principal investigator, UHC Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275087
- Sponsor's protocol ID
- situm1phd
- Acronym
- PSIOS
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If there is a need and desire on the part of other researchers, data on patients without personal data can be shared
Publications
Diniz JA, Siqueira ADS, Araujo GM, Faro TF, Torres LHS, Oliveira E Silva ED, Laureano Filho JR. Intraoral Approach for Surgical Treatment of Psammomatoid Juvenile Ossifying Fibroma. J Craniofac Surg. 2020 May/Jun;31(3):e306-e309. doi: 10.1097/SCS.0000000000006171.
PubMed 31934971Ferreira, C. C., Pereira, M. B. F., Bruzinga, F. F. B., Castro, H. H. O., Souto, G. R., Souza, P. E. A., & De Oliveira, L. J. (2022, September). AN UNUSUAL INTRAORAL LIPOMA: A CASE REPORT. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 134(3), e119. https://doi.org/10.1016/j.oooo.2022.01.212
Frerich, B. (2020). Complications in Maxillofacial Tumor Surgery. Complications in Cranio-Maxillofacial and Oral Surgery, 253-277. https://doi.org/10.1007/978-3-030-40150-4_13
Tamunobelema, D. M. S., & Uruaka, C. I. (2023, March 11). General Anaesthetic Agents and its Implication on the Cardiovascular System: A Systemic Review. Saudi Journal of Medical and Pharmaceutical Sciences, 9(03), 171-183. https://doi.org/10.36348/sjmps.2023.v09i03.006
Qurbani, B., & Karim, S. B. (2022, December 29). Comparison among complications of common intravenous anesthetic drugs during general anesthesia for patients undergoing surgery in Sulaimani city. Annals of the College of Medicine, Mosul, 44(2), 159-165. https://doi.org/10.33899/mmed.2022.136178.1166
Fiorda-Diaz, J., Stoicea, N., & Bergese, S. (2017). Anesthetic Agents. Essentials of Neuroanesthesia, 123-129. https://doi.org/10.1016/b978-0-12-805299-0.00007-5
Hao X, Ou M, Zhang D, Zhao W, Yang Y, Liu J, Yang H, Zhu T, Li Y, Zhou C. The Effects of General Anesthetics on Synaptic Transmission. Curr Neuropharmacol. 2020;18(10):936-965. doi: 10.2174/1570159X18666200227125854.
PubMed 32106800Monisha, B., Madhusudhana, R., & Sujatha, M. (2023). Effects of Isoflurane versus Propofol for Postoperative Neurocognitive Recovery in Patients Undergoing Surgery under General Anaesthesia: A Randomised Clinical Study. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH. https://doi.org/10.7860/jcdr/2023/62147.17888
Mayhew D, Mendonca V, Murthy BVS. A review of ASA physical status - historical perspectives and modern developments. Anaesthesia. 2019 Mar;74(3):373-379. doi: 10.1111/anae.14569. Epub 2019 Jan 15.
PubMed 30648259Saha, D. S. C., & Seraji, D. S. I. (2023, April 16). A Comparative Study of Propofol and Sevoflurane for General Anesthesia in Laparoscopic Appendectomy. Scholars Journal of Applied Medical Sciences, 11(04), 753-757. https://doi.org/10.36347/sjams.2023.v11i04.014
Yang L, Chen Z, Xiang D. Effects of intravenous anesthesia with sevoflurane combined with propofol on intraoperative hemodynamics, postoperative stress disorder and cognitive function in elderly patients undergoing laparoscopic surgery. Pak J Med Sci. 2022 Sep-Oct;38(7):1938-1944. doi: 10.12669/pjms.38.7.5763.
PubMed 36246684Miao L, Lv X, Huang C, Li P, Sun Y, Jiang H. Long-term oncological outcomes after oral cancer surgery using propofol-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia: A retrospective cohort study. PLoS One. 2022 May 13;17(5):e0268473. doi: 10.1371/journal.pone.0268473. eCollection 2022.
PubMed 35559987Zhou, Y., & Xu, T. (2022, January 24). Effect of propofol and sevoflurane on perioperative and postoperative outcomes in lung cancer patients after thoracoscopic surgery. Tropical Journal of Pharmaceutical Research, 20(4), 873-879. https://doi.org/10.4314/tjpr.v20i4.30
Wu L, Li Y, Si J. Effects of sevoflurane and propofol on postoperative nausea and vomiting in patients with colorectal cancer placed under general anesthesia: a systematic review and meta-analysis. J Gastrointest Oncol. 2022 Dec;13(6):2963-2972. doi: 10.21037/jgo-22-783.
PubMed 36636047Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06275087
- Acronym / sponsor ID
- PSIOS / situm1phd
- Conditions
- Intraoral Tumor
- Keywords
- TIVA, Propofol, Intraoral surgery, Postoperative recovery, recovery of muscle strenght
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After obtaining the approval of the ethics committee of KBC Zagreb and the Faculty of Dentistry of the University of Zagreb, the research will be conducted at KBC Zagreb.
Criteria for patient inclusion are:
- patients older than 18 years
- ASA status 1-2,
- Patients who have an indication for an intraoral surgical procedure (intraoral tumor excisions) longer than 30 minutes.
- patients who agreed to the research and signed the consent
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
Participants will be randomly divided (1:1 randomisation) according to a predetermined randomization table (32) into the TIVA group and the Volatile group. After identification of the participants in the operating room, participants will be fitted with a peripheral venous line, electrocardiogram monitoring, non-invasive blood pressure measurement, pulse oximeter, capnograph, temperature probe, and bispectral index (BIS) of the electroencephalogram and neuromuscular monitoring, kinemiography with train-of-four (TOF , M-NMT, Drägerwerk AG \& Co. KGaA,) by recording the responses.
The initial anesthesiological induction procedure will not differ in both groups of patients. The drugs that will be used are sufentanil 0.3mcg/kg, propofol 2mg/kg, and cisatracurium 0.1mg/kg.
Participants will be intubated with an endotracheal tube and mechanically ventilated with a mixture of oxygen and air (inspiratory fraction of oxygen 40%) with a total flow of gas mixture of 3 L/min.
Anesthesia will be maintained in the volatile group with the inhaled anesthetic sevoflurane and single doses of cisatracurium. Cisatracurium will be repeated when the TOF ratio is greater than 5%, and the repeat dose will be 0.01 mg/kg. The depth of anesthesia will be controlled by BIS, maintaining values between 25 and 50. Recommended drug doses will be guided by TOF and BIS values.
In the TIVA group, anesthesia will be maintained with a continuous infusion of propofol (5-10 mg/kg/h) and single doses of cisatracurium. Cisatracurium will be repeated when the TOF ratio is greater than 5%, and the repeat dose will be 0.01 mg/kg. The depth of anesthesia will be controlled by BIS, maintaining values between 25 and 50. Recommended drug doses will be guided by TOF and BIS values.
At the end of the surgical intervention in both groups, the neuromuscular block will be antagonized with prostigmine (0.05 mg/kg) along with atropine (0.01 mg/kg) as soon as the patient begins to breathe spontaneously. Patients will then be extubated when the TOF index is greater than 90%
Muscle strength of all participants will be measured with a JAMAR hand dynamometer, and bite force with a gnathodynamometer (Bite force sensor, Monad electronics) in four time intervals:
- Before introduction to anesthesia
- After waking up from anesthesia in the operating room
- 1 hour after waking up from anesthesia in the recovery room
- After 24 hours from the operation
All patients will fill out the Quality of recovery-40 (Qor-40) questionnaire for assessing the quality of recovery after anesthesia and surgery in four time intervals:
- Before introduction to anesthesia
- 1 hour after waking up from anesthesia in the recovery room
- After 24 hours from the operation
- After 30 days from the operation Consent for the use of the QoR-40 questionnaire was obtained by the main researcher from the author, Professor P.S. Myles, and Dr. M. Miklić Bublić, who translated the questionnaire into Croatian.
Postoperative nausea and vomiting and postoperative shivering will also be recorded, as a binary outcome (yes/no), by visual assessment and interaction with the patient.
The time from the end of the operation to waking up will be monitored. Pain will also be recorded based on QoR40 and the visual analogue scale (VAS-scale) for pain assessment. The patient's chronic therapy is recorded, as is the need for postoperative analgesia.
Assuming medium to large effect size, test power of 80% and use of independent t-test for the primary objective and x2 test for the secondary objective with a statistical significance of 0.05, it is necessary to take a sample of 42 patients, 21 subjects per group. . The test for power calculation is G Power Version 3.1.9.6 (46). Assuming that part of the respondents will not be able to follow up until the end of the research, a sample of 50 patients will be taken, that is, 25 patients in each group. A review of similar studies confirmed the sample size (18,47,48). The results will be processed with IBM SPSS statistics v27. For scalar parametric data, the independent Student t test will be used, for non-parametric data, the Mann-Whitney U test, while categorical data will be processed with the Pearson χ² test. One interim analysis for feasibility and precision estimation is planned.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Experimental | Drug: PropofolThe study involves patients in an operating room undergoing standard procedures. The induction procedure for anesthesia is the same for both groups, using sufentanil, propofol, and cisatracurium. In the TIVA group, anesthesia is maintained with continuous propofol infusion and intermittent cisatracurium doses, guided by neuromuscular and electroencephalogram monitoring. At the end of surgery, neuromuscular block is reversed, and extubation occurs when the train-of-four (TOF) index is over 90%. Muscle strength and bite force are measured at different intervals before and after anesthesia, using specific instruments. Additionally, patients fill out the Quality of recovery-40 (Qor-40) questionnaire at various time points to assess the quality of recovery after surgery and anesthesia. |
| Volatile group | Active comparator | Drug: SevofluraneIn the volatile group, anesthesia is maintained with inhaled sevoflurane and intermittent cisatracurium doses. Cisatracurium is repeated based on TOF ratio, and anesthesia depth is controlled by BIS, maintaining values between 25 and 50. Drug doses are adjusted according to TOF and BIS values. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: TIVAThe experimental group will not receive volatile anesthetic, instead, they will receive propofol infusion | Drug | TIVA group |
| SevofluraneAlso: general volatile anesthesiaThe control group will not receive TIVA, instead, they will receive sevoflurane via inhalation | Drug | Volatile group |
Primary outcome
"Quality of recovery from anesthesia" QoR-40 questionnaire
Time frame: 1 hour, 24 hour, 30 day
The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). The total score and subscales of the QoR-40 are measured using a five-point Likert scale (for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed) and individual scores are then added together, with the minimum score being 40 points and the maximum score being 200 points. The QoR-40 was specifically designed to measure a patient's health status after surgery and anesthesia, and its completion time generally ranges from three to 10 min. The Japanese version of the QoR-40 was also validated according to standard methods of cultural adaptation and psychometric analysis in 2011.
3 secondary outcomes
bite strength and hand grip strength
Time frame: after waking in OR up to 10 min, 1 hour after waking, 24 hour after waking
Postoperative nausea and vomiting
Time frame: 24 hours
Postoperative shivering
Time frame: 2 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 31934971Diniz JA, Siqueira ADS, Araujo GM, Faro TF, Torres LHS, Oliveira E Silva ED, Laureano Filho JR. Intraoral Approach for Surgical Treatment of Psammomatoid Juvenile Ossifying Fibroma. J Craniofac Surg. 2020 May/Jun;31(3):e306-e309. doi: 10.1097/SCS.0000000000006171.
- BackgroundFerreira, C. C., Pereira, M. B. F., Bruzinga, F. F. B., Castro, H. H. O., Souto, G. R., Souza, P. E. A., & De Oliveira, L. J. (2022, September). AN UNUSUAL INTRAORAL LIPOMA: A CASE REPORT. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 134(3), e119. https://doi.org/10.1016/j.oooo.2022.01.212
- BackgroundFrerich, B. (2020). Complications in Maxillofacial Tumor Surgery. Complications in Cranio-Maxillofacial and Oral Surgery, 253-277. https://doi.org/10.1007/978-3-030-40150-4_13
- BackgroundTamunobelema, D. M. S., & Uruaka, C. I. (2023, March 11). General Anaesthetic Agents and its Implication on the Cardiovascular System: A Systemic Review. Saudi Journal of Medical and Pharmaceutical Sciences, 9(03), 171-183. https://doi.org/10.36348/sjmps.2023.v09i03.006
- BackgroundQurbani, B., & Karim, S. B. (2022, December 29). Comparison among complications of common intravenous anesthetic drugs during general anesthesia for patients undergoing surgery in Sulaimani city. Annals of the College of Medicine, Mosul, 44(2), 159-165. https://doi.org/10.33899/mmed.2022.136178.1166
- BackgroundFiorda-Diaz, J., Stoicea, N., & Bergese, S. (2017). Anesthetic Agents. Essentials of Neuroanesthesia, 123-129. https://doi.org/10.1016/b978-0-12-805299-0.00007-5
- Background: PubMed 32106800Hao X, Ou M, Zhang D, Zhao W, Yang Y, Liu J, Yang H, Zhu T, Li Y, Zhou C. The Effects of General Anesthetics on Synaptic Transmission. Curr Neuropharmacol. 2020;18(10):936-965. doi: 10.2174/1570159X18666200227125854.
- BackgroundMonisha, B., Madhusudhana, R., & Sujatha, M. (2023). Effects of Isoflurane versus Propofol for Postoperative Neurocognitive Recovery in Patients Undergoing Surgery under General Anaesthesia: A Randomised Clinical Study. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH. https://doi.org/10.7860/jcdr/2023/62147.17888
- Background: PubMed 30648259Mayhew D, Mendonca V, Murthy BVS. A review of ASA physical status - historical perspectives and modern developments. Anaesthesia. 2019 Mar;74(3):373-379. doi: 10.1111/anae.14569. Epub 2019 Jan 15.
- BackgroundSaha, D. S. C., & Seraji, D. S. I. (2023, April 16). A Comparative Study of Propofol and Sevoflurane for General Anesthesia in Laparoscopic Appendectomy. Scholars Journal of Applied Medical Sciences, 11(04), 753-757. https://doi.org/10.36347/sjams.2023.v11i04.014
- Background: PubMed 36246684Yang L, Chen Z, Xiang D. Effects of intravenous anesthesia with sevoflurane combined with propofol on intraoperative hemodynamics, postoperative stress disorder and cognitive function in elderly patients undergoing laparoscopic surgery. Pak J Med Sci. 2022 Sep-Oct;38(7):1938-1944. doi: 10.12669/pjms.38.7.5763.
- Background: PubMed 35559987Miao L, Lv X, Huang C, Li P, Sun Y, Jiang H. Long-term oncological outcomes after oral cancer surgery using propofol-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia: A retrospective cohort study. PLoS One. 2022 May 13;17(5):e0268473. doi: 10.1371/journal.pone.0268473. eCollection 2022.
- Individual participant dataSharing planned: No. If there is a need and desire on the part of other researchers, data on patients without personal data can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Šitum, MD principal investigator
UHC Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Intraoral Tumor, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Quality of recovery from anesthesia" QoR-40 questionnaire (time frame: 1 hour, 24 hour, 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06275087, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.