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

Primary Purpose

Total Intravenous Anesthesia, Inhalational Anesthesia, Surgical Stress Response

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Target Controlled Infusion
Target Controlled Infusion and maintenance by sevoflurane
Target Controlled Infusion and lidocaine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Intravenous Anesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients subjected to lower abdominal cancer surgery. Patients of both sexes body mass index < 35 kg/m2. Age from 18 to 60 years. ASA, I-III and NYHA, I-III. Exclusion Criteria: Patients with a history of severe cardiovascular or respiratory disease. Severe hepatic, renal, or neurological diseases.

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Target Controlled Infusion

Target Controlled Infusion and maintenance by sevoflurane

Target Controlled Infusion and lidocaine

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 23, 2023
Last Updated
October 7, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT06024733
Brief Title
Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response
Official Title
Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Intravenous Anesthesia, Inhalational Anesthesia, Surgical Stress Response, Target-controlled Infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Target Controlled Infusion
Arm Type
Experimental
Arm Description
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
Arm Title
Target Controlled Infusion and maintenance by sevoflurane
Arm Type
Experimental
Arm Description
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.
Arm Title
Target Controlled Infusion and lidocaine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Target Controlled Infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Target Controlled Infusion and maintenance by sevoflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Target Controlled Infusion and lidocaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
The level of the stress response by serum level of insulin-like growth factors
Description
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 2hours after surgery
Secondary Outcome Measure Information:
Title
The Intensity of pain
Description
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.
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients subjected to lower abdominal cancer surgery. Patients of both sexes body mass index < 35 kg/m2. Age from 18 to 60 years. ASA, I-III and NYHA, I-III. Exclusion Criteria: Patients with a history of severe cardiovascular or respiratory disease. Severe hepatic, renal, or neurological diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noha A Galal, MD
Phone
00201091007572
Email
nohaali153@yahoo.com
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noha A Galal, MD
Phone
00201091007572
Email
nohaali153@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sahar A Mohamed, MD
First Name & Middle Initial & Last Name & Degree
Ahmed H Othman, MD
First Name & Middle Initial & Last Name & Degree
Fatma A Diab, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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