DeliriumPhase 4NCT03078946
Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery
A Phase 4 study testing Dexmedetomidine Hydrochloride and Morphine and Midazolam in people with Delirium, run by Ain Shams University.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Dexmedetomidine Hydrochloride and Morphine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery; a Randomized, Double-blind Clinical Trial
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.
Read the detailed 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.
- Conditions
- Delirium
- Being tested
- Dexmedetomidine Hydrochloride, Morphine and Midazolam
- Keywords
- Cardiac surgery, delirium, dexmedetomidine, morphine, midazolam
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
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
Morphine and MidazolamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group (N=30) | Active comparator | Not described Receives: Drug: Dexmedetomidine Hydrochloride |
| Morphine with Midazolam (N=30) | Active comparator | Not described Receives: Drug: Morphine and Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Delirium (Number of Patients (in Digits))
Measured: 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)
Measured: The maximum serum CRP level during the ICU stay was designated as max-CRP on day 7 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study startMar 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078946
- Sponsor's protocol ID
- 1775
- Status last verified
- Jul 2023
- First submitted
- 3 Mar 2017
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29628826
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery; a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03078946
- Acronym / sponsor ID
- 1775
- Conditions
- Delirium
- Keywords
- Cardiac surgery, delirium, dexmedetomidine, morphine, midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Posted 28 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group (N=30) | Active comparator | Drug: Dexmedetomidine Hydrochloride |
| Morphine with Midazolam (N=30) | Active comparator | Drug: Morphine and Midazolam |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine Hydrochloride30 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 | Drug | Dexmedetomidine Group (N=30) |
| Morphine and Midazolam30 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. | Drug | Morphine with Midazolam (N=30) |
Primary outcome
The Incidence of Delirium (Number of Patients (in Digits))
Time frame: 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)
Time frame: The maximum serum CRP level during the ICU stay was designated as max-CRP on day 7 post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29628826Azeem 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.
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5875204/Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine Hydrochloride and Morphine and Midazolam in people with Delirium, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Delirium (Number of Patients (in Digits)) (time frame: Delirium was reported on day 7 post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03078946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.