Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03078946 |
Other study ID # |
1775 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
March 2013 |
Est. completion date |
April 2015 |
Study information
Verified date |
July 2023 |
Source |
Ain Shams University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Upon arrival at the ICU, a standardized protocol for postoperative care was implemented for
all patients. Infusion rates for all sedative protocols were titrated in order to achieve and
maintain light sedation (RASS -2 to +1) before extubation and (RASS 0) after extubation. All
patients were extubated when deemed clinically appropriate according to local protocols.
Because of their specific pharmacologic properties (i.e., respiratory depression), patients
were weaned off propofol or midazolam infusions before extubation, whereas patients receiving
dexmedetomidine were extubated while still on the medication and were kept on the maintenance
infusion as deemed clinically necessary for a maximum of 24 hours.
Initial assessment and stabilization of both patient groups include; Clinical examination,
hemodynamics (invasive blood pressure, heart rate, drains), activated clotting time,
electrocardiography, chest x-ray and arterial blood gases including sodium and potassium. All
patients were allowed to take 200 μg fentanyl and 5mg midazolam immediately on admission.
Daily electrocardiography, chest x-ray, arterial blood gases including sodium and potassium,
kidney function, coagulation profile if valve surgery or bleeding occurred, liver function if
delirium occurred and CRP quantitative titre.
Delirium was monitored and reassessed up to a maximum of 7 days after surgery and the
assessment takes place in two steps; Firstly, the level of consciousness must be assessed
using the Richmond Agitation-Sedation Scale. If the patient appears to have a RASS score≥3,
then evaluation of delirium using the Confusion Assessment Method for the Intensive Care Unit
(CAM-ICU) can be performed. The CAM-ICU includes the assessment of 4 different features;
acute change or fluctuating course of mental status, inattention, altered level of
consciousness and disorganized thinking. CAM-ICU is considered positive when features 1 and 2
and either 3 or 4 are present (11). The CAM-ICU was performed once daily before midday,
independent of additional analgesia or sedation. Abnormal or delirious behavior was recorded
every shift by the bedside nurse (nurse:patient ratio 1:1) and reviewed by the research team.
The number of delirium days was determined by following delirious patients until 7 days after
surgery. Patients were considered delirium-free when they were free of delirium for more than
24 h and alive.