drugset / Trial / NCT03207100
Analgesia-first Minimal Sedation for Spontaneous Intracerebral Hemorrhage Early Antihypertensive Treatment
Completed
338 enrolled
Hong Yang
Department of Biostatistics, Southern Medical University · collabFifth Affiliated Hospital, Sun Yat-Sen University · collabFirst Affiliated Hospital of Kunming Medical University · collabFirst Affiliated Hospital of Xinjiang Medical University · collabGuangdong 999 Brain Hospital · collabHenan Provincial People's Hospital · collabLanZhou University · collabMaoming People's Hospital · collabPeople's Hospital of Guangxi Zhuang Autonomous Region · collabQilu Hospital of Shandong University · collabSecond Affiliated Hospital of Third Military Medical University · collabShenzhen Second People's Hospital · collabThe Fifth Affiliated Hospital of Southern Medical University · collabThe First Affiliated Hospital of Hunan University of Traditional Chinese Medicine · collabThe Second Hospital University of South China · collabXuanwu Hospital, Beijing · collabZhongshan People's Hospital, Guangdong, China · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This study evaluates safety and efficacy of analgesia-first minimal sedation as an early antihypertensive treatment for spontaneous intracerebral hemorrhage. The analgesia-first minimal sedation strategy relies on the remifentanil-mediated alleviation of pain-induced stress response and the antisympathetic activity of dexmedetomidine to restore the elevated blood pressure to normal level in patients with spontaneous intracerebral hemorrhage. This strategy allows rapid stabilization of blood pressure, and its use as a pre-treatment for patients on mechanical ventilation prior to painful procedures reduces blood pressure variability and thereby results in etiologic treatment. It is more effective in blood pressure control than conventional symptomatic antihypertensive treatment, reduces the incidence of early hematoma expansion and improves prognosis, ,lowers healthcare workers workload, increases patient adherence, and improves healthcare worker satisfaction.
Timeline
- Start
- 2017-12-06
- Primary completion
- 2021-02-14
- Completion
- 2021-05-15
Publications
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- Results Manning L, Hirakawa Y, Arima H, Wang X, Chalmers J, Wang J, Lindley R, Heeley E, Delcourt C, Neal B, Lavados P, Davis SM, Tzourio C, Huang Y, Stapf C, Woodward M, Rothwell PM, Robinson TG, Anderson CS; INTERACT2 investigators. Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial. Lancet Neurol. 2014 Apr;13(4):364-73. doi: 10.1016/S1474-4422(14)70018-3. Epub 2014 Feb 13.
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- Dong R, Li F, Xu Y, Chen P, Maegele M, Yang H, Chen W. Safety and efficacy of applying sufficient analgesia combined with a minimal sedation program as an early antihypertensive treatment for spontaneous intracerebral hemorrhage: a randomized controlled trial. Trials. 2018 Nov 6;19(1):607. doi: 10.1186/s13063-018-2943-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.2 ug/kg | — |
| Subject | Labetalol | Small molecule | 1 mg | Intravenous |
| Subject | Nicardipine | Small molecule | 0.5 ug/kg | Intravenous |
| Subject | Remifentanil | Small molecule | 0.025 ug/kg | Intravenous |
| Subject | Remifentanil | Small molecule | 0.05 ug/kg | Intravenous |
| Subject | Urapidil | Small molecule | 2 mg | Intravenous |
Indications
No indication recorded.