The Role of Ketamine and Dexmedetomidine in Opioid-Sparing Analgesia

NCT05474183 | Completed

• 1 other identifier: H123
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Optimal multimodal opioid-sparing analgesic technique is considered as one of the most important Enhanced recovery pathways (ERPs) or enhanced recovery after surgery (ERAS) interventions that mitigate the undesirable effects of surgical stress response. Implementation of ERP has been shown to reduce postoperative complications and shorten the hospital LOS.

Conditions

Ketamine-Induced Mood Disorder

Keywords

ketamine; dexmedetomidine; Analgesia; Cardiac Surgery; Sedation

Outcome Measures

Primary Outcomes (1)

• The total postoperative fentanyl consumption (μg)

  the total doses of postoperative fentanyl consumption in (μg)

  the first 48 hours postoperative

Secondary Outcomes (1)

• Duration of mechanical ventilation

  the first 48 hours postoperative

Study Arms (3)

Group (K)

ACTIVE COMPARATOR

Group (K): (n=30) will receive ketamine infusion 1-2 μg/kg/min (0.12 mg/kg/h) titrated to desired level of sedation.

Drug: Ketamine

Group (D)

ACTIVE COMPARATOR

Group (D): (n=30) will receive Dexmedetomidine infusion 0.1- 0.2 μg/kg/hour titrated to desired level of sedation.

Drug: Ketamine

Group (C)

PLACEBO COMPARATOR

Group (C): (n=30) will receive fentanyl only.

Drug: Ketamine

Interventions

Ketamine DRUG

drug

Also known as: dexmedetomidine

Group (C); Group (D); Group (K)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65 years
• Ejection fraction (EF) \> 35%
• Elective isolated CABG
• Valve surgery, Atrial septal defect (ASD) closure
• Cross clamp time ≤ 90 min
• Cardiopulmonary bypass time ≤ 120 min.

You may not qualify if:

• Poor left ventricular function with intra-aortic balloon pump support
• Recent myocardial infarction (last seven days)
• Combined procedure (i.e., CABG + other heart/vascular procedure)
• Emergency surgery, and Redo surgery,Hepatic or renal failure, creatinine \>1.5 -History of neurological disorders or convulsions

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related Publications (2)

• Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

  PMID: 29026331 BACKGROUND

• Chapman CR, Vierck CJ. The Transition of Acute Postoperative Pain to Chronic Pain: An Integrative Overview of Research on Mechanisms. J Pain. 2017 Apr;18(4):359.e1-359.e38. doi: 10.1016/j.jpain.2016.11.004. Epub 2016 Nov 28.

  PMID: 27908839 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR OF ANESTHESIA

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 26, 2022
• Study Start: August 5, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 20, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)