A CLINICAL TRIAL COMPARING DEXMEDETOMIDINE AND MIDAZOLAM AS INTRAVENOUS SEDATIVE DURING SPINAL ANAESTHESIA.

Not Applicable

Completed

Conditions: Health Condition 1: null- ASA physical status I and II of either sex, aged between 18-45 years

Registration Number: CTRI/2014/02/004376

Lead Sponsor: orth Bengal Medical College and Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 64

Inclusion Criteria

ASA physical status I and II of either sex, aged between 18-45 years scheduled to undergo elective infraumbilical surgeries under spinal anaesthesia of approximate duration of 2 hours.

Exclusion Criteria

a.Patient not willing to accept spinal anaesthesia

b.Patient not willing to receive sedation during surgery under spinal anaesthesia

c.Patient not willing to participate in the study

d.Patient having any of the followingâ??

I.neurological disease

II.local infection at the site of inducing the block

III.spinal deformity, past history of spine surgery or trauma

IV.coagulopathy

V.psychiatric illness

VI.any history of allergy to the drugs to be used for the study

VII.any significant cardiovascular and pulmonary disease

VIII.impaired liver or kidney function

IX.drug or alcohol use

X.pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time to awakening from sedation (with dexmedetomidine or midazolam) utilizing <br/ ><br> (i) Bispectral Index Score (BIS)14, <br/ ><br> (ii) Observer Assessment of Alertness/Sedation (OAAS/S) Score <br/ ><br>Timepoint: TIME TO ACHIEVE BIS 90 FROM STOPPING INFUSION <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Time taken for onset of sedation to attain a BIS score 70. <br/ ><br>2.OAA/S scores at BIS scores of 70 and 90. <br/ ><br>3.Intraoperative haemodynamic parameters (Mean arterial pressure, Heart rate). <br/ ><br>4.Intraoperative respiratory parameters (SpO2,Respiratory rate). <br/ ><br>5.Patientsâ?? satisfaction regarding quality of intraoperative sedation. <br/ ><br>6.Incidences of adverse events if any. <br/ ><br>Timepoint: every 10 mins until operation is over.