NCT06275087 — Differences in Speed of Recovery From Anesthesia for Intraoral Surgery · CancerIndex
Clinical trial · Interventional
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
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Intraoral Tumor
—
UNRESOLVED
—
Interventions
Interventions (2)
Intervention
Type
Mapped drug
Match
Propofol
Drug
—
UNRESOLVED
Sevoflurane
Drug
—
UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
EXPERIMENTAL
label
TIVA group
description
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.
interventionNames
Drug: Propofol
type
ACTIVE_COMPARATOR
label
Volatile group
description
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.
interventionNames
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
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
References
Publications (32)
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Drug: Sevoflurane
Primary outcomes (1)
measure
"Quality of recovery from anesthesia" QoR-40 questionnaire
timeFrame
1 hour, 24 hour, 30 day
description
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.
Secondary outcomes (3)
measure
bite strength and hand grip strength
timeFrame
after waking in OR up to 10 min, 1 hour after waking, 24 hour after waking
description
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.
measure
Postoperative nausea and vomiting
timeFrame
24 hours
description
determine the difference in the frequency of postoperative nausea and vomiting
measure
Postoperative shivering
timeFrame
2 hour
description
determine the difference in the frequency of postoperative shivering
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