Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery

NCT03078946 | Completed Phase 4 Results

• 1 other identifier: 1775
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized double-blind parallel clinical study was conducted on 60 patients undergoing elective cardiac surgery under general anesthesia, at least 60 yr old, ASA I and II, 70-100 kg body weight and height 160-180 cm. Patients were randomized to: group A=30 patients receiving dexmedetomidine infusion (0.4- 0.7 µg /kg/h) or group B= 30 patients receiving morphine in a dose of 10-50μg/kg/hr as an analgesic with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg repeated as needed. Titration of the study medications infusions was conducted to maintain light sedation (RASS) (-2 to +1). Primary outcome was the prevalence of delirium measured daily via Confusion Assessment Method for intensive care. If Delirium and agitation occurred: haloperidol 2.5-5 mg IV was given in repeated boluses. Secondary outcomes included ventilation time, additional sedation/analgesia, hemodynamics and adverse effects.

Conditions

Delirium

Keywords

Cardiac surgery; delirium; dexmedetomidine; morphine; midazolam

Outcome Measures

Primary Outcomes (2)

• The Incidence of Delirium (Number of Patients (in Digits))

  Delirium was reported on day 7 post-surgery

• The C-reactive Protein (CRP) Quantitative Titer Daily as Part of the Routine Clinical Care as a Prognostic Factor for Delirium (mg/L)

  The maximum serum CRP level during the ICU stay was designated as max-CRP on day 7 post-surgery

Study Arms (2)

Dexmedetomidine Group (N=30)

ACTIVE COMPARATOR

Drug: Dexmedetomidine Hydrochloride

Morphine with Midazolam (N=30)

ACTIVE COMPARATOR

Drug: Morphine and Midazolam

Interventions

Dexmedetomidine Hydrochloride DRUG

30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h

Dexmedetomidine Group (N=30)

Morphine and Midazolam DRUG

30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed.

Morphine with Midazolam (N=30)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective cardiac surgery under general anesthesia
• at least 60 yr old
• ASA physical status I and II
• kg body weight
• height 160-180 cm.

You may not qualify if:

• Patients with impaired kidney or liver functions
• history of cardiac or central nervous system disease
• uncontrolled medical disease (diabetes mellitus and hypertension)
• coagulation defect
• history of drug or alcohol abuse
• history of chronic pain or daily intake of analgesics
• history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
• allergy to the used medications
• or patient's refusal

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• Azeem TMA, Yosif NE, Alansary AM, Esmat IM, Mohamed AK. Dexmedetomidine vs morphine and midazolam in the prevention and treatment of delirium after adult cardiac surgery; a randomized, double-blinded clinical trial. Saudi J Anaesth. 2018 Apr-Jun;12(2):190-197. doi: 10.4103/sja.SJA_303_17.

  PMID: 29628826 RESULT

Related Links

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5875204/

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Morphine; Midazolam

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Dr. Ibrahim Mamdouh Esmat
• Organization: Ain-Shams University Hospitals

ibrahim_mamdouh@med.asu.edu.eg

01001241928

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 14, 2017
• Study Start: March 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 25, 2023
• Results First Posted: August 28, 2020

Record last verified: 2023-07