Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response

Phase 4

Active, not recruiting

• Conditions: Total Intravenous Anesthesia; Inhalational Anesthesia; Surgical Stress Response; Target-controlled Infusion
• Interventions: Drug: Target Controlled Infusion; Drug: Target Controlled Infusion and lidocaine; Drug: Sevoflurane

• Registration Number: NCT06024733
• Lead Sponsor: Assiut University

Brief Summary

This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response.

Detailed Description

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 .

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Study Start: 2023-10-07
• Status Verified: 2024-08
• Primary Completion: 2024-08-01
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients subjected to lower abdominal cancer surgery.
2. Patients of both sexes
3. body mass index < 35 kg/m2.
4. Age from 18 to 60 years.
5. ASA, I-II.

Exclusion Criteria

1. Patients with a history of severe cardiovascular or respiratory disease.
2. Severe hepatic, renal, or neurological diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Target Controlled Infusion	Target Controlled Infusion	-
Target Controlled Infusion and lidocaine	Target Controlled Infusion and lidocaine	-
inhalational	Sevoflurane	-

Primary Outcome Measures

Name	Time	Method
The level of the stress response by serum level of insulin-like growth factors	Intraoperative and 24hours after surgery	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.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt