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

NCT ID: NCT06024733

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-07

Study Completion Date

2024-12-01

Brief Summary

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

Detailed Description

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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 .

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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inhalational

Group Type SHAM_COMPARATOR

Sevoflurane

Intervention Type DRUG

patient recieve propofol for induction and sevoflurane for maintenance

Target Controlled Infusion

Group Type ACTIVE_COMPARATOR

Target Controlled Infusion

Intervention Type DRUG

target controlled infusion of propofol

Target Controlled Infusion and lidocaine

Group Type ACTIVE_COMPARATOR

Target Controlled Infusion and lidocaine

Intervention Type 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.

Interventions

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Sevoflurane

patient recieve propofol for induction and sevoflurane for maintenance

Intervention Type DRUG

Target Controlled Infusion

target controlled infusion of propofol

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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group 1 GROUP 2 GROUP3

Eligibility Criteria

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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-II.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Noha Ali Galal

Assistant lecturer of Anesthesia, ICU and pain Relief South Egypt Cancer Institute- Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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525

Identifier Type: -

Identifier Source: org_study_id

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