Comparison Of The Sedative Effects Of Intravenous Dexmedetomidine Versus Midazolam Plus Fentanyl For Post Operative Elective Mechanical Ventilation  A Randomised Control Trial

INTRODUCTION

Sedation and analgesia are regarded as integral part of treatment of patients in Icu.

Mechanically ventilated patients in Icu will require sedation to facilitate better synchrony with the ventilator. It also blunts the symphathetic response during specific procedures such as tracheal aspiration, physiotherapy and catheter placements.

The consequences of inadequate sedation and analgesia can be substantial including self removal of Endotracheal tube, aggressive behaviour by patient against care providers and poor patient- ventilator synchrony.

JUSTIFICATION

Midazolam plus Fentanyl is the standard drug used as infusion for sedation of mechanically ventilated patients in ICU.

Dexmedetomidine a novel alpha-2 adrenergic agonist has been used in recent times for the purpose of sedation.

  Hence, we compare the dual effects of sedation and analgesia in Dexmedetomidine and midazolam plus fentanyl for the short term sedation of electively mechanical ventilated post operative patients in ICU.

HYPOTHESIS

Equivalent dose of Dexmedetomidine helps in better sedation than equivalent dose of Midazolam plus Fentanyl in elective mechanically ventilated post operative patients in ICU

AIM

To compare the efficacy of Intravenous Dexmedetomidine and Intravenous fentanyl with Midazolam with the help of Richmond Agitation  Sedation Score (RASS).

Primary Objective: 

 To assess the level of sedation with Dexmedetomidine and Midazolam plus Fentanyl  using the Richmond Agitation Sedation Score(RASS).

Secondary Objective

Behavioural pain scale assessment.

Time taken for Extubation.

Hemodynamic changes.

INCLUSION CRITERIA

Age more than 18 years to  less than 60 years

ASA I ,II,III

Mechanical ventilated patients for less than 24hours

EXCLUSION CRITERIA

Patient with decompensated cardiovascular,Neurological,Renal and Hepatic diseases.

Allergy to any of the study drugs

Patient on Ionotropes or Vasopressor support

Pregnant patients.

patient non consent.

patient with chronic opioid dependence.

Blood loss more than 1.5litres.

Study design : randomised control trial-double blinded study.

Study period  : 18 months from institutional ethical commitee approval.

Study place  : department of anaesthesiology(pacu/icu),srm medical college and research institute.

Study population : elective post operative mechanically ventilated patients in icu. 

METHODOLOGY

Simple random sampling was used to select the respondent to the study. The respondent was selected based on the inclusion and exclusion criteria.

Double blinded or masking was used to allocate the participants to a particular group.

 Healthy ambulant patients scheduled for elective neurosurgical, maxillofacial and oral surgeries and surgeries of prolonged duration requiring elective post operative mechanical ventilation were included in the study.

General anaesthesia was standardised among the recruited patients in both the groups.

In group D  inj.Dexmedetomidine will be started as a loading dose of 1mcg /kg over 15minutes  followed by an infusion rate of 0.2 - 0.7 mcg/kg/hour to maintain a RASS score of -3 or -4.

In group MF inj.Midazolam will be given as loading dose of 0.05mg/kg over 15minutes followed by an infusion of 0.05mg/kg/hour. Inj.fentanyl will be started as a loading dose of 1mcg/kg followed. by 1mcg/kg/hour as an iinfusion to maintain a RASS score of -3 or -4.

Inj.paracetamol 15mg/kg infusion 8th hourly will be the analgesic regimen in both the groups.

Inj.tramadol 1.5mg/kg will be used as rescue analgesics.

RASS scoring will be done till the period of extubation.

Hemodynamic monitoring will be done hourly.

Patient will be electively ventilated for 24 hours from the time of admission into the Icu.

The infusion will be stopped at the end of 24 hours

Time to extubation - the time taken from stoppage of infusion to  time to extubation will be noted.

The rescue analgesic requirement will be noted.

complications like need for prolonged ventilation, hemodynamic instability will be noted.

Comparison between Intravenous Dexmedetomidine and Midazolam with Fentanyl for short term Sedation in elective Mechanically Ventilated post operative Patients in Intensive Care Unit.