Skip to main content
OpenTrials
Completed

NCT Number: NCT01445639

Dexmedetomidine in Patients After Intracranial Surgery

Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent sedation and analgesia without respiratory depression. Dexmedetomidine has been used in critically ill medical, surgical, and pediatric patients. No study has been designed specifically to evaluate dexmedetomidine uses in the neurocritical care population. The primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic analgesia and sedation in patients after intracranial surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

About this study

The PASTrial is a non-commercial, multi-center, randomized, placebo-controlled, double blinded clinical trial. The study compares dexmedetomidine versus normal saline (placebo) in patients after intracranial surgery with delayed extubation. In dexmedetomidine group, infusion (0.4μg/kg/h) is started when patients are admitted to neuro-intensive care unit for postoperative recovery. In control group, patients receive normal saline infusion at the same rate and volume in dexmedetomidine group. The patient's level of sedation is assessed by Sedation-Agitation Scale (SAS) per hour. Midazolam is administered in 0.3-0.5 mg bolus or continuous infusion as SAS above 4. The study is designed primarily to compare the percentage of patients with agitation and requiring midazolam infusion in the 2 study arms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients after intracranial surgery with delayed extubation

Exclusion criteria

  • emergency operation
  • brain stem operation
  • preoperative consciousness disorders or epilepsy
  • bradycardia, hypotension, acute myocardial infarction, second- or third degree heart block, or need continuous infusions of vasopressor before the start of study drug infusion
  • patients enrolled in another trial

Treatment and study plan

Dexmedetomidine

Drug

Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively

normal saline

Drug

as placebo

Primary outcomes

  1. Mean percentage of hours of optimal sedation.

    Time frame: 24 hours postoperative

    Optimal sedation is defined as SAS score 4.

Secondary outcomes

  1. Percentage of patients with agitation and receiving additional sedatives.

    Time frame: During the first 24 hours postoperatively

    Agitation is defined as SAS above 4. Patients are given midazolam as agitation.

Other outcomes

  1. Percentage of patients with adverse events.

    Time frame: During the first 24 hours postoperatively

    Adverse events include hypotension, bradycardia, airway obstruction, apnea, and consciousness disorders

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients After Intracranial Surgery (Prophylactic Analgesia and Sedation Trial, PASTrial)

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 4, 2011
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.