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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06024733
Collaborator
(none)
120
1
3
4.6
26.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Target Controlled Infusion
  • Drug: Target Controlled Infusion and maintenance by sevoflurane
  • Drug: Target Controlled Infusion and lidocaine
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The level of the stress response by serum level of insulin-like growth factors [Intraoperative and 2hours 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.

Secondary Outcome Measures

  1. The Intensity of pain [24 hours after surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noha Ali Galal, Assistant lecturer of Anesthesia, ICU and pain Relief South Egypt Cancer Institute- Assiut University, Assiut University
ClinicalTrials.gov Identifier:
NCT06024733
Other Study ID Numbers:
  • 525
First Posted:
Sep 6, 2023
Last Update Posted:
Sep 6, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 6, 2023