Induction of anaesthesia by using depth of anaesthesia monitors as a guide

Not Applicable

Conditions: Health Condition 1: null- American Society Of Anesthesiologist physical status I and II

Registration Number: CTRI/2015/05/005809

Lead Sponsor: Sir Ganga Ram Hospita

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

This study will include consenting patients aged 20-65 years, of both sex, and belonging to physical status ASA I/II.

Exclusion Criteria

: The exclusion criteria would include patients with uncompensated systemic illness (cardiac, respiratory, neurologic, hepato-renal, and endocrinology), obesity, psychiatric disorders, substance/alcohol abuse, and non-confirmation of informed consent.

Randomisation Allocation and Concealment:

The patients will be randomly allocated to one of the two groups based on a computer-generated random number table (url:stattrek.com/statistics/random-number-generator.aspx). Randomization sequence concealment will include opaque-sealed envelopes with alphabetic codes whose distribution will be in control of an independent analyst. The envelopes will be opened; patientâ??s data-slip will be pasted on them, and will be sent back to the control analyst.

Study Blinding:

The laryngoscopist will be blinded to BIS scores in the conventional/non interventional BIS group.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Percentage â??NIBP-differentialâ?? (from the baseline preoperative NIBP) between the post-anaesthesia induction NIBP and post-laryngoscopy intubation NIBP. (As an index of event-harmonisation) <br/ ><br>2.The incidence of out of range BIS scores <br/ ><br>[â??shallowâ?? (BIS60), â??overly deepâ?? (BIS40)] after: <br/ ><br>a. Induction of anaesthesia <br/ ><br>b. Following direct laryngoscopy-intubation <br/ ><br>Timepoint: 1. Baseline NIBP,HR,BIS <br/ ><br>2.Imediately after induction <br/ ><br>3.At 2min time point post induction <br/ ><br>4. Post intubation. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Assessment of hemodynamic variables (heart rate, NIBP) following anaesthesia induction and laryngoscopy-intubation procedure. (gain on hemodynamic change) <br/ ><br>2.Comparison of anaesthetic depth (BIS scores) following anaesthesia induction and around (pre-/post intubation) the laryngoscopy-intubation event. <br/ ><br>3.Postoperative patient awareness of the direct laryngoscopy and intubation event. <br/ ><br>Timepoint: From anaesthesia induction to 24 hrs post operative period