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Use of Dexmedetomidine for prophylactic analgesia and sedation in delayed extubation patients after craniotomy: a study protocol and statistical analysis plan for a randomized controlled trial

Use of Dexmedetomidine for prophylactic analgesia and sedation in delayed extubation patients after craniotomy: a study protocol and statistical analysis plan for a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-PRC-12002903
Enrollment
Unknown
Registered
2012-12-20
Start date
2012-07-02
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delayed extubation patients after craniotomy

Interventions

Dex group:Dex group:Dexmedetomidine group patients received a continuous infusion of 0.6µg/kg/h(10ug/ml).
Saline group:Saline group:Placebo group patients received a maintenance infusion of 0.9% sodium chloride for injection at a volume and rate equal to that of dexmedetomidine.

Sponsors

ICU, Beijing Tiantan Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All patients after intracranial surgery delayed extubation admitted to our intensive care units are screened daily for study eligibility. Patients are deemed eligible for this study if they are >=18-year old, present with an GCS-M score higher or equal than 5 in 2hr(Time Zero would be the time of ICU dmission).

Exclusion criteria

Exclusion criteria: Exclusion criteria are: patients suffering from liver insufficiency, renal insufficiency, heart rate (HR) less than 50bpm, systolic blood pressure (SBP) less than 90 mm Hg, acute myocardial infarction, second- or third degree atrioventricular block or need continuous infusions of vasopressor before the start of study drug infusionpatients suffering from consciousness disorders or epilepsy before intracranial surgery, patients suffering from Pre-existent dysphagia and cough reflex difference, patients with emergency operation or readmitted to ICU after randomization to the studypatients enrolled in another trial, pregnant or lactating women are not included.

Design outcomes

Primary

MeasureTime frame
mean percentages of time in optimal sedation;

Secondary

MeasureTime frame
The percentage of patients requiring propofol for rescue to achieve/ maintain targeted sedation (SAS);The effects of dexmedetomidine on haemodynamic and recovery responses during extubation;vital signs various and adverse events;Plasma levels of epinephrine, norepinephrine, dopamine,cortisol, NSE and S100-? were detected at before and after takeing medicine at hour 2, 4, 8 and the end of the study;

Countries

China

Contacts

Public ContactJian-Xin Zhou
zhoujx.cn@gmail.com+86 13801183875

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 10, 2026