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NCT Number: NCT06024733

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University

Asyut, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-II.

Exclusion criteria

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

Treatment and study plan

Sevoflurane

Drug

patient recieve propofol for induction and sevoflurane for maintenance

Other names: group 1

Target Controlled Infusion

Drug

target controlled infusion of propofol

Other names: GROUP 2

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.

Other names: GROUP3

Primary outcomes

  1. The level of the stress response by serum level of insulin-like growth factors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 6, 2023
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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