Cardioprotective Effect of Ketamine-dexmeditomidine Versus Fentanyl-midazolam in Open Heart Surgery in Pediatrics

NCT05314569 | Completed Phase 1

• 1 other identifier: N-11-2022
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

congenital hearts are very sensitive and irritable to deal with, especially during repair defects, the child's heart is exposed to impaired myocardial function during the entire procedure. Moreover, reperfusion of the heart during open-heart surgery when the myocardium is exposed to a global ischaemic cardioplegic arrest can induce myocardial injury. Myocardial reperfusion injury activates neutrophils, which trigger an inflammatory response resulting in the generation of reactive oxygen species (ROS), cytokine release, and complement activation, which further induce more cardiac injury. In addition to the inflammatory response generated as a result of tissue reperfusion injury, there is a significant systemic inflammatory response that is triggered by cardiopulmonary bypass (CPB) during open-heart surgery

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• troponin level

  mean troponin level post arotic declamping.

  6 hours

Secondary Outcomes (5)

• heart rates

  every 15 minutes

• aortic cross clamping

  2 hours

• inotropic support

  6 hours

• blood pressure

  every 15 minutes

• need of nitroglycerin infusion

  6 hours

Study Arms (3)

Control group(C)

PLACEBO COMPARATOR

anesthesia will be maintained using Isoflurane 1.2MAC keeping the bispectral index( BIS) between 40-60%.

Drug: Isoflurane

Ketamine-dexmedetomidine group( KD)

ACTIVE COMPARATOR

After induction of anesthesia , dexmedetomidine will be given(1 ug /kg ) over 10 min, then ketamine(2 m/kg) . maintenance throughout the procedure, with the bispectral index between 40 and 60%. by infusing Dexmedetomidine( 0.5 μg/.kg /.h r)) ketamine,( 1 m/kg/hr),

Drug: Ketamine- dexmedetomidine

. Fentanyl- midazolam group (FM)

ACTIVE COMPARATOR

After induction of anesthesia fentanyl( 3 μg/kg), midazolam( 100 ug /kg over 2 to 3 minutes) maintenance throughout the procedure, with the bispectral index between 40 and 60%. by infusing midazolam (1 ug /kg /min)-fentanyl( 2 μg/kg/h ).

Drug: Fentanyl- midazolam

Interventions

Ketamine- dexmedetomidine DRUG

ketamine - Dexmedetomidine combination had superior cardioprotective effects as measured by cardiac markers as compared to sevoflurane- sufentanil anesthesia after cardiac surgery

Ketamine-dexmedetomidine group( KD)

Fentanyl- midazolam DRUG

Midazolam is known to have potential anti-inflammatory effects and antioxidant activity. They have been proven to provide protective effects for patients who underwent cardiac surgery.Fentanyl is one opioid that has been closely linked to inflammatory mediators and myocardial protection. It reduces the CPB-induced inflammatory response and ischaemic reperfusion injury during cardiac surgery

. Fentanyl- midazolam group (FM)

Isoflurane DRUG

Anesthetic inhalational gas

Control group(C)

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• the American Society of Anesthesiologists II and III
• elective open Congenital cardiac surgery(VSD, AV canal, and partial anomaly) using cardiopulmonary bypass

You may not qualify if:

• less than 6 months or more than 24 months.
• weight \< 5 kg.
• cyanotic heart disease
• patients with heart failure, an implantable pacemaker, pulmonary hypertension, preoperative administration of inotropic agents, serum creatinine higher than1.5 mg/dL, chronic liver disease, patients receiving sulfonylurea, theophylline, or allopurinol

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amany Hassan Saleh

Giza, 02, Egypt

Location

MeSH Terms

Interventions

Isoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals

Study Officials

• Amany H Saleh, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: patients will be allocated to the study using a computer-generated random list and the group assignments will be sealed in opaque envelopes that will be opened after induction. The drugs will be prepared by an anesthetist who is blind to the study groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia ,surgical intensive care and pain management ,Cairo University

Model Details: patients will be allocated to three groups

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 6, 2022
• Study Start: April 15, 2022
• Primary Completion: September 20, 2022
• Study Completion: September 25, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

EG (1)