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

NCT06024733 | Active Not Recruiting Phase 4

• 1 other identifier: 525
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Total Intravenous Anesthesia; Inhalational Anesthesia; Surgical Stress Response; Target-controlled Infusion

Outcome Measures

Primary Outcomes (1)

• 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 24hours after surgery

Study Arms (3)

inhalational

SHAM COMPARATOR

Drug: Sevoflurane

Target Controlled Infusion

ACTIVE COMPARATOR

Drug: Target Controlled Infusion

Target Controlled Infusion and lidocaine

ACTIVE COMPARATOR

Drug: Target Controlled Infusion and lidocaine

Interventions

Sevoflurane DRUG

patient recieve propofol for induction and sevoflurane for maintenance

Also known as: group 1

inhalational

Target Controlled Infusion DRUG

target controlled infusion of propofol

Also known as: GROUP 2

Target Controlled Infusion

Target Controlled Infusion and lidocaine DRUG

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

Target Controlled Infusion and lidocaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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-II.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Interventions

Sevoflurane; Lidocaine

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesia, ICU and pain Relief South Egypt Cancer Institute- Assiut University

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 6, 2023
• Study Start: October 7, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: for one year after the end of study
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)