Differences in Speed of Recovery From Anesthesia for Intraoral Surgery

NCT06275087 | Recruiting

• 1 other identifier: situm1phd
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraoral Tumor

Keywords

TIVA; Propofol; Intraoral surgery; Postoperative recovery; recovery of muscle strenght

Outcome Measures

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.

  1 hour, 24 hour, 30 day

Secondary Outcomes (3)

• bite strength and hand grip strength

  after waking in OR up to 10 min, 1 hour after waking, 24 hour after waking

• Postoperative nausea and vomiting

  24 hours

• Postoperative shivering

  2 hour

Study Arms (2)

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.

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.

Drug: Sevoflurane

Interventions

Propofol DRUG

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

Also known as: TIVA

TIVA group

Sevoflurane DRUG

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

Also known as: general volatile anesthesia

Volatile group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

RECRUITING

Related Publications (32)

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MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Ivan Šitum, MD

  UHC Zagreb

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Šitum, MD

CONTACT

0915143620; ivsitum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invesigator

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 23, 2024
• Study Start: April 10, 2024
• Primary Completion: November 5, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)