SUMMARY

 NAME OF INVESTIGATOR: DR. SHAIKH MOHD MUDASSIR.

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

 NAME OF HOSPITAL: SAIFEE HOSPITAL, MUMBAI.

 AIMS AND OBJECTIVES:

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

            ii.            COMPARISON OF THE EFFICACY OF MIDAZOLAM AND DEXMEDETOMIDINE WITH RESPECT TO THE CARDIO-RESPIRATORY PARAMETERS AS FOLLOWING:-

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 operation theatres, 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  elective General surgery,Orthopaedic,Urologic and Gynecology surgeries. The cases will include 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 collection technique:

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

8.5       Data analysis:

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

Group X1:  Patients will receive Initial loading dose of Dexmedetomidine (0.5 μg/kg) over 10 min followed by infusion at 0.2 μg · kg^−1 Â· h^−1 from the 50-mL “Infusion” syringe.

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

Group X0: Patients will receive 1 mL bolus from the 10 mL “Bolus” syringe( 1 mg midazolam or 0.02mg/kg) followed by 0.5 mL boluses every 30 min after the 1^st hour of 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 taken after explaining the goal of the study in the language best understood by them. Standard monitoring of Spo2, non-invasive blood pressure (NIBP) and heart (HR) rate will be done and recorded as baseline values and at regular intervals as per the protocol. For, qualitative data result presented with the help of Frequency and Percentage table, association among study group will be assessed with the help of Chi-Square test.

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