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Differences in Speed of Recovery From Anesthesia for Intraoral Surgery

ConditionIntraoral Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinical Hospital Centre Zagreb

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Propofol

    Drug

    The experimental group will not receive volatile anesthetic, instead, they will receive propofol infusion

  • Sevoflurane

    Drug

    The control group will not receive TIVA, instead, they will receive sevoflurane via inhalation

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: TIVA groupExperimental treatment 1 intervention
Group B: Volatile groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

"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

Secondary outcomes

1

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
2

Postoperative nausea and vomiting

determine the difference in the frequency of postoperative nausea and vomiting

Time frame
24 hours
3

Postoperative shivering

determine the difference in the frequency of postoperative shivering

Time frame
2 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinical Hospital Centre Zagreb

Lead sponsor

Source ClinicalTrials.gov
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