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This study was planned as a single-center, prospective, randomized trial. Adult patients undergoing elective spinal surgery lasting longer than three hours, performed in a neurosurgery operating room, will be evaluated. Patients managed with three different anesthesia methods currently used will be examined for recovery patterns:
Recovery patterns include; extubation time, eye opening time, emergence agitation, postoperative nausia and vomiting and postoperative recovery unit discharge time.
The aim of this study was to compare the effects of different anesthesia methods applied in spinal surgeries lasting longer than three hours on postoperative recovery time. Specifically, it aimed to determine the contribution of low-dose (0.5 MAC) desflurane or sevoflurane combined intravenous anesthesia (CIVIA) approaches compared to total intravenous anesthesia (TIVA) on recovery parameters such as patient recovery time, extubation time, and time to consciousness. It also aimed to investigate whether the desflurane-containing combination resulted in a faster recovery than the sevoflurane-containing combination.
TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic efect site model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring.
Outputs:
Eye opening time (the time from the end of anesthesia until the patient's eye opening for verbal stimuli) Extubation time (the time from the end of anesthesia until extubation) Richardson agitation sedation and RAMSEY scale values, and Emergence agitation incidence.
Postoperative nausea and vomiting incidence (PONV). Time to discharge from the PACU and time to an Aldrate score >9 will be calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane combined with TIVA | Experimental | Combined anesthesia with sevoflurane and intravenous agents. A 0.5 MAC sevoflurane combined with TIVA. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring. |
|
| Desflurane combined with TIVA | Experimental | Combined anesthesia with desflurane + intravenous agents. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring. Efect site concentration will be aimed for TIVA |
|
| TIVA | Experimental | Total Intravenous Anesthesia. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring. Efect Site concentration will be aimed. for sole TIVA, 2-4mcg/ml propofol and 1-4ng/ml remifentanil will bu used according to BIS monitoring. 40-60 range will be used for BIS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevofluorane | Drug | In this group of patients, <0.5 MAC sevoflurane will be used in combination with TIVA. (TIVA method described above) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extubation time | Extubation time in patients after all anesthetic drugs have been discontinued | First postoperative hour |
| Measure | Description | Time Frame |
|---|---|---|
| Eye opening | time brtween anesthesia terminated and aye opening after surgery | First postoperative hour |
| Measure | Description | Time Frame |
|---|---|---|
| Richmond Agitation-Sedation Scale (RASS) | Richmond Agitation-Sedation Scale (RASS) A 10-point scale ranging from +4 (combative) to -5 (unarousable). Measures agitation, sedation level, and responsiveness. Helps guide sedation management and assess recovery from anesthesia. | first 2 hours postoperatively |
| Postoperative Nausia and Vomiting |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmet YUKSEK, MD | Contact | 05326580351 | mdayuksek@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmet YUKSEK, Md | Kocaeli City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli City Hospital | Recruiting | Kocaeli | Izmıt | Yozgat | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33588751 | Background | Wolf A, Selpien H, Haberl H, Unterberg M. Does a combined intravenous-volatile anesthesia offer advantages compared to an intravenous or volatile anesthesia alone: a systematic review and meta-analysis. BMC Anesthesiol. 2021 Feb 15;21(1):52. doi: 10.1186/s12871-021-01273-1. | |
| 38590312 | Background | Song T, Wu LJ, Li L. Comparison of combined intravenous and inhalation anesthesia and total intravenous anesthesia in laparoscopic surgery and the identification of predictive factors influencing the delayed recovery of neurocognitive function. Front Med (Lausanne). 2024 Mar 25;11:1353502. doi: 10.3389/fmed.2024.1353502. eCollection 2024. |
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Participant: The participant will be unaware of which anesthesia method is involved in the perioperative period.
Care Provider: The second anesthesiologist is responsible for the patient's recovery after the anesthesia is terminated and will be unaware of which anesthetic method was used.
|
| Desflurane | Drug | In this group of patients, <0.5 MAC Desflurane will be used in combination with TIVA. |
|
|
| Total Intravenous Anesthesia(TIVA) | Drug | In this group, TIVA will be applied with the combination of BIS-guided propofol + remifentanil. |
|
|
Postoperative Nausia and Vomitting incidance |
| First 2 postoperative hours |
| PACU discharge time | The time between the termination of anesthesia and the patient being discharged from the postoperative recovery room (PACU) with an Aldrete score of >9. It is calculated in minutes. | First 2 postoperative hours |
| 33157991 | Background | Wang Y, Cao M, Cao G, Liu Y, Zhang Y. Effect of combined intravenous-inhalation anesthesia on postoperative cognitive dysfunction after laparoscopic radical resection of cervical cancer: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Nov 6;99(45):e23124. doi: 10.1097/MD.0000000000023124. |
| ID | Term |
|---|---|
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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