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

BISPECTRAL INDEX GUIDED HARMONISATION OF ANAESTHESIA INDUCTION AND TRACHEAL INTUBATION PROCEDURES: A RANDOMISED CONTROLLED STUDY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/05/005809
Enrollment
180
Registered
2015-05-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Group I: Conventional nonintervention group: The patients will be applied BIS strips on their forehead before induction of anaesthesia and corresponding BIS score will be noted along wi

Sponsors

Sir Ganga Ram Hospita
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Amitabh Dutta

Sir Ganga Rram Hospital

drmoloyrajkhowa@gmail.com8800629919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026