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NCT Number: NCT06957470

TCI vs. Manuel TIVA in Septorhinoplasty Surgeries

Septorhinoplasty is a surgical technique that can be used to correct various nasal deformities.Total intravenous anesthesia (TIVA) is a frequently preferred method as an anesthesia technique in septorhinoplasty surgeries.It has been reported that TIVA reduces the incidence of postoperative nausea and vomiting, is more successful in acute postoperative pain control compared to inhalational anesthesia, provides more stable hemodynamics, provides quicker awakening after anesthesia, is more effective in preventing recovery agitation and cough, and is effective in controlled hypotension.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguladk Bulent ecevit University, Zonguldak, Kozlu, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-65 years with American Society of Anesthesiology (ASA) physical status I-II who will undergo Septorhinoplasty Surgery under general anesthesia will be included in the study.

Exclusion criteria

Patients who do not agree to participate in the study Patients under 18 and over 65 Patients with ASA score III and above Clinical diagnosis of neuropsychiatric disorders Those with a history of chronic NSAID, tranquilizer, opioid or sleeping pill use Clinical diagnosis of Serious cardiac diseases Clinical diagnosis of central-autonomic nervous system disease Clinical diagnosis of Coagulopathy Those with soybean oil allergy and a history of allergy to any study drug BMI >30 kg m2, pregnancy breastfeeding patients

Treatment and study plan

Total intravenous anesthesia

Procedure

It is a general anesthesia technique performed through a combination of intravenous agents administered intravenously by various methods.

Primary outcomes

  1. postoperative recovery

    Time frame: at postoperative 6 hours and 24 hours

    Postoperative recovery will evaluate with quality of recovery-40 questionnaire. quality of recovery-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).

  2. agitation during emergence

    Time frame: Postoperative 0 and 15. Minutes at the recovery room

    Agitation will evaluate with richmond sedation agitation scale. The richmond sedation agitation scale is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation.

Secondary outcomes

  1. surgeon satisfaction

    Time frame: at the end of surgery

    5-point Likert Scale

  2. postoperative pain

    Time frame: at the end of the surgery

    Numeric Rating Scale at the PACU

  3. nausea and vomiting

    Time frame: Postoperative 0 hours at recovery room

    4-point Likert Scale

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

Comparison of the Effects in Target-controlled and Manually Controlled Total Intravenous Anesthesia on Postoperative Recovery and Patient Quality of Recovery in Septorhinoplasty Surgeries

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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