Trial Outcomes & Findings for Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery (NCT NCT03078946)

NCT ID: NCT03078946

Last Updated: 2023-07-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: Delirium was reported on day 7 post-surgery
• Results posted on: 2023-07-25

Participant Flow

Patients were excluded if: (1) patient's refusal, (2) allergy to any drugs of the study, (3) history of drug or alcohol abuse, (4) history of uncontrolled diabetes or hypertension, (5) history of chronic pain or daily intake of analgesics within 24 h before surgery, and (6) impaired kidney or liver functions.

Participant milestones

Measure	Dexmedetomidine Group (N=30) Dexmedetomidine Hydrochloride: 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 With Midazolam (N=30) Morphine and Midazolam: 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.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Dexmedetomidine Group (N=30) n=30 Participants Dexmedetomidine Hydrochloride: 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 With Midazolam (N=30) n=30 Participants Morphine and Midazolam: 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.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical >=65 years	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Age, Continuous	65.3 years STANDARD_DEVIATION 4.8 • n=30 Participants	66.7 years STANDARD_DEVIATION 5.6 • n=30 Participants	65.8 years STANDARD_DEVIATION 5.4 • n=60 Participants
Sex: Female, Male Female	17 Participants n=30 Participants	15 Participants n=30 Participants	32 Participants n=60 Participants
Sex: Female, Male Male	13 Participants n=30 Participants	15 Participants n=30 Participants	28 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: Delirium was reported on day 7 post-surgery

Outcome measures

Measure	Dexmedetomidine Group (N=30) n=30 Participants Dexmedetomidine Hydrochloride: 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 With Midazolam (N=30) n=30 Participants Morphine and Midazolam: 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.
The Incidence of Delirium (Number of Patients (in Digits))	1 participants	2 participants

PRIMARY outcome

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

Outcome measures

Measure	Dexmedetomidine Group (N=30) n=30 Participants Dexmedetomidine Hydrochloride: 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 With Midazolam (N=30) n=30 Participants Morphine and Midazolam: 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.
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 mg/L Standard Deviation 253.29	101 mg/L Standard Deviation 253.3

Adverse Events

Dexmedetomidine Group (N=30)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Morphine With Midazolam (N=30)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexmedetomidine Group (N=30) n=30 participants at risk Dexmedetomidine Hydrochloride: 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 With Midazolam (N=30) n=30 participants at risk Morphine and Midazolam: 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.
Nervous system disorders Delirium	3.3% 1/30	6.7% 2/30

Other adverse events

Measure	Dexmedetomidine Group (N=30) n=30 participants at risk Dexmedetomidine Hydrochloride: 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 With Midazolam (N=30) n=30 participants at risk Morphine and Midazolam: 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.
Nervous system disorders Delirium	3.3% 1/30 • Number of events 1	6.7% 2/30 • Number of events 2

Additional Information

Dr. Ibrahim Mamdouh Esmat

Ain-Shams University Hospitals

Phone: 01001241928

Email: ibrahim_mamdouh@med.asu.edu.eg

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place