An interventional study of Propofol and Sevoflurane in Intraoral Tumor, sponsored by Clinical Hospital Centre Zagreb. Recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Clinical Hospital Centre Zagreb · Not applicable, Interventional, and Supportive care
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.
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:
Exclusion criteria are:
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:
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:
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.
Clinical Hospital Centre Zagreb is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Criteria for patient inclusion are:
The exclusion criteria are:
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.
Drug: Propofol
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.
Drug: Sevoflurane
The experimental group will not receive volatile anesthetic, instead, they will receive propofol infusion
Also known as: TIVA
The control group will not receive TIVA, instead, they will receive sevoflurane via inhalation
Also known as: general volatile anesthesia
"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.
Time frame: 1 hour, 24 hour, 30 day
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.
Time frame: 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
Time frame: 24 hours
Postoperative shivering
determine the difference in the frequency of postoperative shivering
Time frame: 2 hour
Plan to share: 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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Clinical Hospital Centre Zagreb