COMPARISON OF DEXMEDETOMIDINE WITH MIDAZOLAM FOR SEDATION IN ELDERLY PATIENTS UNDERGOING REGIONAL ANAESTHESIA

SUMMARY

 NAME OF INVESTIGATOR: DR. SHAIKH MOHD MUDASSIR.

 NAME OF GUIDE: DR. TASNEEM DHANSURA MD (ANAESTHESIA)

 NAME OF HOSPITAL: SAIFEEHOSPITAL, MUMBAI.

AIMS****AND OBJECTIVES:

i.            COMPARISON OF THE SEDATION PROPERTIES OFDEXMEDETOMIDINE WITH MIDAZOLAM IN ELDERLY WHEN USED FOR INTRAOPERATIVE SEDATIONDURING REGIONAL ANAESTHESIA.

ii.            COMPARISON OF THE EFFICACY OF MIDAZOLAM ANDDEXMEDETOMIDINE WITH RESPECT TO THE CARDIO-RESPIRATORY PARAMETERS ASFOLLOWING:-

1. HEART RATE
2. MEAN ARTERIAL PRESSURE
3. OXYGEN SATURATION
4. RESPIRATORY RATE

MATERIALS AND METHODS:

The study will be done at Saifee Hospital,Mumbai. It is a tertiary care hospital, having well equipped operationtheatres, facility for postoperative monitoring and intensive care units,casualty facilities, cardiac cath lab, blood bank, private & general wards.

Study population:

The study population  will be  Patients  coming  to  the  hospital  for  electiveGeneral surgery,Orthopaedic,Urologic and Gynecology surgeries. The cases willinclude both males/females age >60 yrs.

Sample size and technique:

Sample size: Total 100 Patients

Sample technique: Randomized, Single Centre, Parallel group,Double blinded study.

Data collectiontechnique:

Data  will be  collected  by  history,  observation,  examination  of  patients  on  admission  ona Proforma.

 8.5       Data analysis:

All patients will be divided into two groups of Fifty Patientseach. To facilitate blinding, two syringes of “study drug†will be prepared foreach patient by an anesthesiologist not associated with the study and labeled“Infusion†and “Bolus top-up.†One syringe of each pair will contain activesedative drug(s);  the other will contain placebo (saline).

Group X1:  Patientswill receive Initial loading dose of Dexmedetomidine (0.5 μg/kg) over 10 minfollowed by infusion at 0.2 μg · kg−1 Â· h−1 fromthe 50-mL “Infusion†syringe.

−1 mL Placebo bolus from the 10-mL “Bolus†syringe followed by 0.5mL boluses every 30 min after the 1st hour of surgery.

Group X0: Patientswill receive 1 mL bolus from the 10 mL “Bolus†syringe( 1 mg midazolam or0.02mg/kg) followed by 0.5 mL boluses every 30 min after the 1st hourof surgery.

–Initial loading dose plus Infusion of Placebo from 50 mL“Infusion†syringe at a corresponding rate to the X1 group.

 Written, Informed and Valid consent from patients will be takenafter explaining the goal of the study in the language best understood by them. Standardmonitoring of Spo2, non-invasive blood pressure (NIBP) and heart (HR) rate willbe done and recorded as baseline values and at regular intervals as per theprotocol. For, qualitative data result presented with the help ofFrequency and Percentage table, association among study group will be assessedwith the help of Chi-Square test.

For quantitative data, comparison among study group will be donewith the help of Mann-Whitney test or Unpaired T test as per results ofnormality test.