A Phase 4 interventional study of Sevoflurane and Target Controlled Infusion in Total Intravenous Anesthesia, Inhalational Anesthesia and Surgical Stress Response, sponsored by Assiut University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response.
Target-controlled infusion (TCI) techniques have been used to induce and maintain general anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and pharmacodynamic mathematical modeling to maintain a user-designated target concentration at an effect site (typically the brain).
The clinician enters a desired target concentration for an anesthetic or another agent. The computer calculates the amount of the agent required to achieve the target concentration at the effect site and directs an infusion pump to deliver the calculated boluses or infusions. Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.
Total intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique, effectively controlling responses to tracheal intubation and intense surgical stimulation, while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: Sevoflurane
Drug: Target Controlled Infusion
Drug: Target Controlled Infusion and lidocaine
patient recieve propofol for induction and sevoflurane for maintenance
Also known as: group 1
target controlled infusion of propofol
Also known as: GROUP 2
patients will receive total intravenous anesthesia with propofol Target Controlled Infusion. At the induction of anesthesia, the patients will receive a bolus of lidocaine 1% 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure.
Also known as: GROUP3
The level of the stress response by serum level of insulin-like growth factors
The serum level of insulin-like growth factors will be measured at preoperative, intraoperative after one hour of intubation, at the end of surgery and after extubation, and transfer to the intensive care unit.
Time frame: Intraoperative and 24hours after surgery
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Assiut University