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PSIOSNCT06275087

Differences in Speed of Recovery From Anesthesia for Intraoral Surgery

StatusCompleted
PhaseNot applicable
Primary completion
Track this trial

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Record History

All 8 versions: 6 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 14 words Show 7 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Trial completed
    • Final enrollment: 50 participants (planned 42)
    • Study completion date changed from estimate of Jul 2026 to Jul 30, 2026
    • Study description expanded, about 21 words
    • Site details revised
    • Publications: details revised at 30 of 32 entries
  2. Primary completion date changed from estimate of Mar 2026 to Nov 5, 2025v7
  3. Study description expanded, about 10 wordsv6
  4. Eligibility criteria expanded, about 113 words
    • Study description expanded, about 204 words
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2024 to Apr 10, 2024
    v4
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

"Quality of recovery from anesthesia" QoR-40 questionnaire
Timeframe: 1 hour, 24 hour, 30 day

Secondary (3)

bite strength and hand grip strength
Postoperative nausea and vomiting
Postoperative shivering

Arms and interventions

TIVA groupExperimental

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.

Volatile groupActive 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.

Drugs: Propofol, Sevoflurane

Sites

1 site in 1 country

  • University Hospital Centre ZagrebZagreb, Croatia