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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Dexmedetomidine; Midazolam; Morphine

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