Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients
Condition: Sedation in Critically Ill COPD Patients
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      the investigators conducted a randomized controlled trial in respiratory intensive care unit
      (RICU) of Assiut University Hospital. COPD patients admitted to RICU were included. Exclusion
      criteria include: Marked renal impairment, Liver cell failure, neurological disorders, age
      <18 or >70 and pregnancy.

      Patients were randomly allocated to two groups. Midazolam was used for sedation in both
      groups. Richmond agitation-sedation score (RASS) was used to monitor level of sedation or
      agitation. Control group received daily interruption of sedation. intervention group managed
      by no-sedation strategy.

      Primary outcome measure: changes in PaCO2 Secondary outcome measures include: changes in PH,
      heart rate, mean arterial blood pressure, respiratory rate, P0.1 and NIF.
    

Detailed description: 
      The researchers conducted a randomized controlled trial in respiratory intensive care unit
      (RICU) of Assiut University Hospital. COPD patients admitted to RICU were included. Exclusion
      Criteria include: Marked renal impairment (creatinine > 2mg/dl), Liver cell failure
      (Bilirubin> 3mg/dl), neurological disorders, age <18 or >70 and pregnancy.

      Patients were randomly allocated to two groups. Midazolam was used for sedation in both
      groups. Richmond agitation-sedation score (RASS) was used to monitor level of sedation or
      agitation. Control group received daily interruption of sedation. After intubation, patients
      received IV infusion of midazolam, gradually increasing dose till RASS reached -4 or -5.
      Infusion stopped at 7:00 AM. If the patient is awake no need for resuming infusion. If signs
      of discomfort occurred, infusion resumed at half of the prior dose, targeting conscious
      sedation (RASS 0: -3) Intervention group were managed by no-sedation strategy. Patients
      received bolus doses of midazolam only when needed, after atrial to control agitation by
      correcting the underlying cause. If the patient needed more than 3 bolus doses , IV infusion
      of midazolam was given by the daily interruption protocol as in the control group. No
      crossover was allowed between groups. Analysis was done by intension-to-treat principle.

      Follow up arterial blood gas sampling was done baseline at intubation. 1hr., 2hrs., 12hrs.,
      24hrs. and 48hrs. after intubation. Recording of clinical monitoring parameters (hear rate,
      mean arterial blood pressure, respiratory rate) was done at the same intervals. Airway
      occlusion pressure (P0.1) and negative inspiratory force (NIF) were measured 48 hours after
      intubation to test affection of respiratory muscles in both groups.

      Primary outcome measure: changes in PaCO2 Secondary outcome measures include: changes in PH,
      heart rate, mean arterial blood pressure, respiratory rate, P0.1 and NIF.
    

Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sedation; COPD; critically ill; intensive care