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

Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia

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

Study Overview

• Status: Recruiting
• Conditions: Total Intravenous Anesthesia; Inhalational Anesthesia; Surgical Stress Response; Target-controlled Infusion
• Intervention / Treatment: Drug: Target Controlled Infusion; Drug: Target Controlled Infusion and maintenance by sevoflurane; Drug: Target Controlled Infusion and lidocaine

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noha A Galal, MD; Phone Number: 00201091007572; Email: nohaali153@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University
    • Contact: Noha A Galal, MD; Phone Number: 00201091007572; Email: nohaali153@yahoo.com
    • Sub-Investigator: Sahar A Mohamed, MD
    • Sub-Investigator: Ahmed H Othman, MD
    • Sub-Investigator: Fatma A Diab, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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-III and NYHA, I-III.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Target Controlled Infusion; Patient's age and weight will be entered into the Target Controlled Infusion unit, enabling target propofol concentrations to be set and the infusion to be started. Target induction concentrations will be 4-6 mcg/ ml. and anesthesia will be maintained with Target Controlled Infusion propofol at 3 - 6 mcg/ml as effect site concentration to maintain BIS 40-60	Drug: Target Controlled Infusion; the patient's age and weight will be entered into the Target Controlled Infusion unit enabling target propofol concentrations to be set and the infusion to be started. Target induction concentrations will be 4-6 mcg/ ml. and anesthesia will be maintained with Target Controlled Infusion propofol at 3 - 6 mcg/ml as effect site concentration to maintain BIS 40-60.
Experimental: Target Controlled Infusion and maintenance by sevoflurane; Patients will be induced with intravenous propofol 1.5 mg/kg and fentanyl 1- 2 μg/kg. Tracheal intubation after adequate neuromuscular blockade with rocuronium 0.6 mg/kg will be performed. Anesthesia will be maintained with sevoflurane 2-2.2 % to maintain a target MAC value between 0.8 & 1.0.	Drug: Target Controlled Infusion and maintenance by sevoflurane; patients will be induced with intravenous propofol 1.5 mg/kg and fentanyl 1- 2 μg/kg. Tracheal intubation will be performed after adequate neuromuscular blockade with rocuronium 0.6 mg/kg. Anesthesia will be maintained with sevoflurane 2-2.2 % to maintain a target MAC value between 0.8 & 1.0.
Experimental: Target Controlled Infusion and lidocaine; 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 and 1mg/kg/h for 24 h postoperative.	Drug: Target Controlled Infusion and lidocaine; 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 and 1mg/kg/h for 24 h postoperative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative and 2hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Intensity of pain	The intensity of pain at rest and during pain-provoking movements, deep breathing coughing, mobilization measured by visual analog scale (VAS) pain score immediately postoperative and then at 2, 4, 6,12, and 24 hours after surgery. VAS is from zero to 10. 0: no pain. 10: The worst pain.	24 hours after surgery

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Inhalation; Lidocaine; Sevoflurane
• Other Study ID Numbers: 525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: for one year after the end of study
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No