Health Condition 1: null- American Society Of Anesthesiologist physical status I and II
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 2. The incidence of out of range BIS scores [â??shallowâ?? (BIS60), â??overly deepâ?? (BIS40)] after: a. Induction of anaesthesia b. Following direct laryngoscopy-intubation Timepoint: 1. Baseline NIBP,HR,BIS 2.Imediately after induction 3.At 2min time point post induction 4. Post intubation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of hemodynamic variables (heart rate, NIBP) following anaesthesia induction and laryngoscopy-intubation procedure. (gain on hemodynamic change) 2. Comparison of anaesthetic depth (BIS scores) following anaesthesia induction and around (pre-/post intubation) the laryngoscopy-intubation event. 3. Postoperative patient awareness of the direct laryngoscopy and intubation event. Timepoint: From anaesthesia induction to 24 hrs post operative period | — |
Countries
India
Contacts
Sir Ganga Rram Hospital