Kocaeli City Hospital
Kocaeli, Izmıt, Yozgat, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07123870
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:
1. Total intravenous anesthesia (TIVA), 2. TIVA Combined anesthesia with sevoflurane and intravenous agents (sevoflurane-CIVIA), 3. TIVA Combined anesthesia with desflurane and intravenous agents (desflurane-CIVIA).
Recovery patterns include; extubation time, eye opening time, emergence agitation, postoperative nausia and vomiting and postoperative recovery unit discharge time.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Kocaeli, Izmıt, Yozgat, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In this group of patients, <0.5 MAC sevoflurane will be used in combination with TIVA. (TIVA method described above)
Other names: Sevoflurane Combined Anesthesia
In this group of patients, <0.5 MAC Desflurane will be used in combination with TIVA.
Other names: Desflurane Combined anesthesia
In this group, TIVA will be applied with the combination of BIS-guided propofol + remifentanil.
Other names: Total Intravenous Anesthesia
Time frame: First postoperative hour
Extubation time in patients after all anesthetic drugs have been discontinued
Time frame: First postoperative hour
time brtween anesthesia terminated and aye opening after surgery
Time frame: first 2 hours postoperatively
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.
Time frame: First 2 postoperative hours
Postoperative Nausia and Vomitting incidance
Time frame: First 2 postoperative hours
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.
Contact information is provided by the study sponsor or research team.
Kocaeli City Hospital
Other Gov
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View the official ClinicalTrials.gov record (opens in a new tab)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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