Trial Title:
Differences in Speed of Recovery From Anesthesia for Intraoral Surgery
NCT ID:
NCT06275087
Condition:
Intraoral Tumor
Conditions: Official terms:
Propofol
Sevoflurane
Conditions: Keywords:
TIVA
Propofol
Intraoral surgery
Postoperative recovery
recovery of muscle strenght
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Propofol
Description:
The experimental group will not receive volatile anesthetic, instead, they will receive
propofol infusion
Arm group label:
TIVA group
Other name:
TIVA
Intervention type:
Drug
Intervention name:
Sevoflurane
Description:
The control group will not receive TIVA, instead, they will receive sevoflurane via
inhalation
Arm group label:
Volatile group
Other name:
general volatile anesthesia
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.
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:
1. Before introduction to anesthesia
2. After waking up from anesthesia in the operating room
3. 1 hour after waking up from anesthesia in the recovery room
4. 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:
1. Before introduction to anesthesia
2. 1 hour after waking up from anesthesia in the recovery room
3. After 24 hours from the operation
4. 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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Centre Zagreb
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Status:
Recruiting
Contact:
Last name:
Ivan Šitum
Phone:
0915143620
Email:
ivsitum@gmail.com
Investigator:
Last name:
Ivan Šitum
Email:
Principal Investigator
Start date:
April 10, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Clinical Hospital Centre Zagreb
Agency class:
Other
Source:
Clinical Hospital Centre Zagreb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06275087
