Trial Outcomes & Findings for Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance (NCT NCT03395886)

NCT ID: NCT03395886

Last Updated: 2019-11-29

Results Overview

NIV failure was defined by reintubation or death in the course of this study

• Recruitment status: COMPLETED
• Target enrollment: 90 participants
• Primary outcome timeframe: 72 hours after the initiation of sedation
• Results posted on: 2019-11-29

Participant Flow

Participant milestones

Measure	Remifentanil Group Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min. Remifentanil: The noninvasive ventilation intolerant patients was sedated by remifentanil.	Dexmedetomidine Group Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine.
Overall Study STARTED	52	38
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	52	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance

Baseline characteristics by cohort

Measure	Remifentanil Group n=52 Participants Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min. Remifentanil: The noninvasive ventilation intolerated patients was sedated by remifentanil.	Dexmedetomidine Group n=38 Participants Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. Dexmedetomidine: The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.	Total n=90 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	67 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	52 Participants n=5 Participants	38 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	52 Participants n=5 Participants	38 Participants n=7 Participants	90 Participants n=5 Participants
baseline NIV intolerance score NIV intolerance score of 4	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
baseline NIV intolerance score NIV intolerance score of 3	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants
baseline NIV intolerance score NIV intolerance score of 2	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
baseline NIV intolerance score NIV intolerance score of 1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours after the initiation of sedation

Population: Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.

NIV failure was defined by reintubation or death in the course of this study

Outcome measures

Measure	Remifentanil Group n=52 Participants Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min. Remifentanil: The noninvasive ventilation intolerant patients was sedated by remifentanil.	Dexmedetomidine Group n=38 Participants Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine.
Number of Participants With NIV Failure	10 Participants	8 Participants

SECONDARY outcome

Timeframe: 72 hours after the initiation of sedation

Population: The generalized estimating equations approach was employed to analyze changes in the mitigation rate over time between the two groups.

Mitigation was defined by patients who were relieved from the initial intolerant status

Outcome measures

Measure	Remifentanil Group n=52 Participants Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min. Remifentanil: The noninvasive ventilation intolerant patients was sedated by remifentanil.	Dexmedetomidine Group n=38 Participants Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine.
Number of Participants With NIV Mitigation	44 Participants	31 Participants

Adverse Events

Remifentanil Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Dexmedetomidine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr Zhe Luo

Zhongshan Hospital, Fundan university

Phone: 64041990

Email: ec@zs-hospital.sh.cn

Results disclosure agreements

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