Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients

NCT06490731 | Recruiting Phase 1

• 1 other identifier: New valley anesthesia 4
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory response and hemodynamic response in patients with intraabdominal sepsis and Effects of Dexmedetomidine versus ketamine on it .

Conditions

Haemodynamic Rebound

Outcome Measures

Primary Outcomes (1)

• blood pressure

  Effect of the study drugs as sedative agents on blood pressure in mechanically ventilated septic patients after abdominal exploration for intestinal surgery.

  48 hours

Study Arms (2)

Patients will receive dexmedetomidine

ACTIVE COMPARATOR

Patients will receive dexmedetomidine (Precedex®; 200 µg/2 ml; at one µg/kg loading dose over 10 minutes followed by a 0.5 µg/kg/hr. maintenance dose for 48 hours Dexmedetomidine will be diluted in normal saline at a 4 µg/ ml concentration

Drug: Dexmedetomidine

Patients will receive ketamine

ACTIVE COMPARATOR

Patients will receive ketamine at one mg/kg IV loading dose over 10 minutes, then a continuous infusion starting at 300 µg /kg/hr over 48 hours

Drug: Ketamine

Interventions

Dexmedetomidine DRUG

Patients will receive dexmedetomidine

Patients will receive dexmedetomidine

Ketamine DRUG

patients Will receive ketamine

Patients will receive ketamine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients admitted to ICU after ileus surgery (perforated viscus, infarcted bowel, strangulated hernia, anastomotic leakage, diverticulitis, and intestinal obstruction), and who will be expected to require postoperative sedation and ventilation.
• Abdominal sepsis was determined as organ dysfunction with a substantial change in overall SOFA score (2) ≥ 2 points because of intra-abdominal sepsis.

You may not qualify if:

• Known allergy to ketamine, dexmedetomidine,
• Confirmed pregnancy,
• Heart failure (class 3 or 4 of the New York Heart Association),
• Renal failure (RIFLE classification),
• Liver failure (manifested by serum total protein concentration \<3 g/dl and total bilirubin \>5 mg/dl)
• Known or suspected brain death.
• Patients who receive neuromuscular blockers during the first 48 hours of ICU admission will also be excluded.

Sponsors & Collaborators

• New Valley University: lead

Study Sites (1)

asyut University

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ahmed Ismail Abdel Sabour, MD

  NewValley University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Ismail ABDEL sabour, MD

CONTACT

01097845491; ahmed_ismail87@med.nvu.edu.eg

ayman Mohamed Fawzy, Msc

CONTACT

01028697487; fawzyayman629@med.nvu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture of anesthesia and ICU

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 8, 2024
• Study Start: April 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2024-11

Locations

EG (1)