Hemodynamic Effects of Bolus of Ketamine Versus Fentanyl in Patients With Septic Shock

NCT ID: NCT05957302

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-12-15

Brief Summary

Ketamine is a commonly used drug for sedation and induction of anesthesia in patients with shock and/or cardiac dysfunction. Ketamine is characterized by its cardiovascular stimulatory effect due to increase release of endogenous catecholamines. On the other hand, laboratory data on the isolated human myofibers suggest that ketamine had a direct myocardial depressive effect; accordingly, many experts believe that ketamine might have a negative hemodynamic effect in catecholamine depleted patients such as critically ill patients. In critically ill patients, there are contradicting results for the effect of ketamine on the hemodynamic profile and there is paucity of clinical data about the effect of ketamine on cardiac contractility and cardiac output (CO). Cardiac output is the primary determinant of global oxygen delivery to organs and maintaining stable CO in critically ill patients is at most importance to avoid further organ damage in such patients.

Therefore, this study is designed to evaluate the effect a single bolus of ketamine on CO in patients with septic shock in comparison to fentanyl bolus.

Detailed Description

Patients meeting the inclusion criteria will receive the study drug according to the randomization, if a bolus of sedation is required for resuming sedation after sedation vacation. All patients will be monitored by 5-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure.

Hypotension defined as mean arterial pressure < 65 mmHg and will be managed by increasing the norepinephrine infusion rate by 20%.

Bedside echocardiography will be used to measure the cardiac output by an experienced physician who is not aware of the nature of the study drug. The left ventricular outflow diameter (LVOT) will be measured in the parasternal long-axis view. Then velocity time integral (VTI) will be measured from the apical five-chamber view. The average of three VTI readings will be calculated.

The cardiac output will be calculated by the equation:

CO = π X (LVOT diameter/2) X VTI X heart rate Delta CO% will be calculated as percentage of change at each time point in relation to the baseline measurement the CO, heart rate, mean blood pressure will be measured before drug administration and at 3, 6, 10 and 15 min after drug administration

Conditions

Ketamine; Fentanyl; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine group

bolus of sedation for resuming sedation after sedation vacation

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

100 mg of ketamine diluted in 10 mL saline (10 mg /mL) and patient will receive 0.1 mL/kg

Fentanyl group

bolus of sedation for resuming sedation after sedation vacation

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

100 mcg of fentanyl diluted in 10 mL saline (10 mcg /mL) and patient will receive 0.1 mL/kg

Interventions

Ketamine

100 mg of ketamine diluted in 10 mL saline (10 mg /mL) and patient will receive 0.1 mL/kg

Intervention Type: DRUG

Fentanyl

100 mcg of fentanyl diluted in 10 mL saline (10 mcg /mL) and patient will receive 0.1 mL/kg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult (>18 years) patients.
• With septic shock on vasopressor therapy
• Mechanically ventilated
• Need for sedation

Exclusion Criteria

• Hemodynamic instability (MAP <65 mmHg) despite appropriate volume replacement and vasopressor therapy
• Noradrenaline infusion rate <0.05 mcg/kg/min
• Poor cardiac window on the ultrasound.
• Known allergy to study drugs
• Neurocritical patients with signs of increased intracranial tension

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hasanin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ahmed hasanin, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University Kasr Alainy Faculty of Medicine

Locations

Ahmed Mohamed Hasanin

Cairo, , Egypt

Countries

Egypt

References

Mostafa M, Hasanin A, Reda B, Elsayad M, Zayed M, Abdelfatah ME. Comparing the hemodynamic effects of ketamine versus fentanyl bolus in patients with septic shock: a randomized controlled trial. J Anesth. 2024 Dec;38(6):756-764. doi: 10.1007/s00540-024-03383-9. Epub 2024 Aug 18.

Reference Type: DERIVED

PMID: 39154316 (View on PubMed)

Other Identifiers

MS-47-2023

Identifier Type: -

Identifier Source: org_study_id