Evidence map›Paper›PMID 30400977›Full record

Trial reportTrials2018

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.

Rui Dong, Fen Li, Ying Xu, Pingyan Chen, Marc Maegele, Hong Yang, Wenjin Chen

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03207100 (Clinical Study of the Safety and Efficacy of Analgesia-first Minimal Sedation as an Early Antihypertensive Treatment for Spontaneous Intracerebral Hemorrhage), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03207100 nacompletednot on this map

Clinical Study of the Safety and Efficacy of Analgesia-first Minimal Sedation as an Early Antihypertensive Treatment for Spontaneous Intracerebral Hemorrhage

TypeinterventionalSponsorHong YangRan2017 to 2021Enrolled338ConditionsEarly Systolic Blood Pressure Control Rate, Hematoma Growth, Blood Pressure Variability, Healthcare Worker SatisfactionArmsAnalgesia-first minimal sedation, Antihypertensive treatment
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Rui DongDepartment of Intensive Care Unit, The Third Affiliated Hospital of Southern Medical University, No.183 West Zhongshan Ave, Tianhe District, Guangzhou, 510630, Guangdong, China.
Fen LiDepartment of Intensive Care Unit, The Third Affiliated Hospital of Southern Medical University, No.183 West Zhongshan Ave, Tianhe District, Guangzhou, 510630, Guangdong, China.
Ying XuDepartment of Biostatistics, School of Public Health, Southern Medical University, 1838 North Guangzhou Avenue, Guangzhou, 510515, China.
Pingyan ChenDepartment of Biostatistics, School of Public Health, Southern Medical University, 1838 North Guangzhou Avenue, Guangzhou, 510515, China.
Marc MaegeleInstitute for Research in Operative Medicine (IFOM), Witten/Herdecke University (Campus Cologne-Merheim), Ostmerheimerstr. 200, 51109, Cologne, Germany.
Hong YangDepartment of Intensive Care Unit, The Third Affiliated Hospital of Southern Medical University, No.183 West Zhongshan Ave, Tianhe District, Guangzhou, 510630, Guangdong, China. yhicu_1103@163.com.ORCID http://orcid.org/0000-0003-0869-3369
Wenjin ChenDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, 45 Changchun Street, Xicheng District, Beijing, 100053, China. drchenwenjin@qq.com.
Third Affiliated Hospital of Southern Medical University · CNSouthern Medical University · CNCapital Medical University · CNWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSpontaneous intracerebral hemorrhage (ICH) is a serious threat to human health. Although early blood pressure (BP) elevation is closely associated with a poor prognosis, the optimal antihypertensive regimen for acute-phase ICH remains controversial. In ICH, pain, sleep deprivation, and stress are usually the main causes of dramatic BP increases. While traditional antihypertensive treatment resolves the increased BP, it does not address the root cause of the disease. Remifentanil relieves pain and, when combined with dexmedetomidine's antisympathetic action, can restore elevated BP to normal levels. Here, we seek to validate the efficacy and safety of applying sufficient analgesia in combination with a minimal sedation program versus antihypertensive drug therapy for the early and rapid stabilization of BP in ICH patients. METHODS/

designWe are conducting a multicenter, prospective, randomized controlled, single-blinded, superiority clinical trial across 15 hospitals. We will enroll 354 subjects in mainland China, and all subjects will be randomized into experimental and control groups in which they will be given remifentanil combined with dexmedetomidine or antihypertensive drugs (urapidil, nicardipine, and labetalol). The primary endpoint will be the systolic BP control rate within 1 h of treatment initiation, and the efficacy and safety of the antihypertensive regimens will be compared between the two groups. Secondary endpoints include the incidence rate of early hemorrhage growth, neurological function, duration of intensive care unit (ICU) stay, and staff satisfaction with the treatment process. DISCUSSION: We hypothesize that applying sufficient analgesia in combination with minimal sedation will act as an effective and safe antihypertensive strategy in ICH and that this treatment strategy could, therefore, be widely used as an ICH acute-phase therapy.

trial registrationClinicalTrials.gov, ID: NCT03207100 . Registered on 22 July 2017.

Indexed as

AnalgesiaProcedural SedationAntihypertensive AgentsCerebral HemorrhageClinical Trials Data Monitoring CommitteesData Interpretation, StatisticalDexmedetomidineHumansHypertensionOutcome Assessment, Health CarePharmacovigilanceProspective StudiesRemifentanilSample SizeSingle-Blind MethodAntihypertensive AgentsDexmedetomidineRemifentanilClinical trialEarly antihypertensive treatmentIntracerebral hemorrhageMinimal sedationSufficient analgesia

Identifiers

PMID30400977
PMCPMC6219080
OpenAlexW2899910184

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.