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Value of bispectral index under optimal conscious sedation, at which airway tube could be feasibly inserted into trachea through nose route by the help of endoscopic instrument

Optimal level of bispectral index for conscious sedation in awake fiberoptic nasotracheal intubation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/07/014810
Enrollment
94
Registered
2018-07-11
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- Patient posted for any elective surgery, who are diagnosed as difficult airway on pre-anaesthetic evaluation, requiring awake fiberoptic nasotracheal intubation for general anaesthesia

Interventions

Intervention1: Achieving adequate conscious sedation (BIS â?¤90 and RSS â?¥2) to be followed by awake fibreoptic nasotracheal intubation: Procedure will start with nebulization by 2.5 mL of 4% lidocai

Sponsors

Department of Anaesthesiology AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists- Physical Status Class 1 and 2 Ability to give informed consent for awake fiberoptic nasotracheal intubation

Exclusion criteria

Exclusion criteria: Emergency procedures Known allergy to studied medications Difficult mask ventilation Pregnancy Known hearing or visual problems Mental retardation End-organ impairment Any contraindication to nasotracheal intubation

Design outcomes

Primary

MeasureTime frame
Stable BIS: the lowest bispectral index value at which awake fiberoptic nasotracheal intubation could be feasibly performedTimepoint: At Baseline (time 0) just before initiation of nebulization At 15 min after nebulization At two minutes intervals thereafter till patient is intubated

Secondary

MeasureTime frame
Any drug requirement and total doseTimepoint: Throughout the period of observation after starting the procedure, till patient is intubated;Bispectral index value when any complication occurredTimepoint: Throughout the period of observation after starting the procedure, till patient is intubated;ComplicationsTimepoint: Throughout the period of observation after starting the procedure, till patient is intubated;Correlation between bispectral index and cardiorespiratory eventsTimepoint: Throughout the period of observation after starting the procedure, till patient is intubated;Correlation between bispectral index and ramsay sedation scoreTimepoint: At Baseline (time 0) just before initiation of nebulization At 15 min after nebulization At two minutes intervals thereafter till patient is intubated;Ramsay Sedation scoreTimepoint: At Baseline (time 0) just before initiation of nebulization At 15 min after nebulization At two minutes intervals thereafter till patient is intubated;Total duration of procedureTimepoint: The period of observation after starting of procedure, till patient is intubated

Countries

India

Contacts

Public ContactDr Gaurav Jain

All India Institute of Medical Sciences Rishikesh

gauravhld@gmail.com8808631209

Outcome results

None listed

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