Phase 4
N=60
Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery
Delirium
Bottom Line
View on ClinicalTrials.gov: NCT03078946 ↗Enrolled (actual)
60
Serious AEs
5.0%
Results posted
Aug 2020
Primary outcome: Primary: The Incidence of Delirium (Number of Patients (in Digits)) — 1; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine Hydrochloride (Drug); Morphine and Midazolam (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Ain Shams University
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Delirium (Number of Patients (in Digits)) |
1; 2 | — |
| PRIMARY The C-reactive Protein (CRP) Quantitative Titer Daily as Part of the Routine Clinical Care as a Prognostic Factor for Delirium (mg/L) |
127.1; 101 | — |
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.
Eligibility Criteria
Inclusion Criteria
- elective cardiac surgery under general anesthesia
- at least 60 yr old
- ASA physical status I and II
- 70-100 kg body weight
- height 160-180 cm.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03078946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.