TCI vs. Manuel TIVA in Septorhinoplasty Surgeries

NCT06957470 | Active Not Recruiting

• 1 other identifier: ZBEU-BHIZAL-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anesthesia

Keywords

septorhinoplasty; TIVA (total intravenous anesthesia); TCI (target controlled infusion)

Outcome Measures

Primary Outcomes (2)

• postoperative recovery

  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).

  at postoperative 6 hours and 24 hours

• agitation during emergence

  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.

  Postoperative 0 and 15. Minutes at the recovery room

Secondary Outcomes (3)

• surgeon satisfaction

  at the end of surgery

• postoperative pain

  at the end of the surgery

• nausea and vomiting

  Postoperative 0 hours at recovery room

Study Arms (2)

TCI (target controlled infusion)

Patients in the TCI group will be anesthetized using the infusion method that selects the target area of effect of propofol and remifentanil.

Procedure: Total Intravenous Anesthesia

MCI (manuel controlled infusion)

Patients in the MCI group will be administered propofol and remifentanil as an infusion based on the anesthesiologist's observations.

Procedure: Total Intravenous Anesthesia

Interventions

Total Intravenous Anesthesia PROCEDURE

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

MCI (manuel controlled infusion); TCI (target controlled infusion)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18-65 years with American Society of Anesthesiology (ASA) physical status I-II who will undergo Septorhinoplasty Surgery under general anesthesia

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (2)

Zonguladk Bulent ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Bulent Ecevit University

Zonguldak, Zonguldak Province, 67600, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: May 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)