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Comparison of BIS monitoring vs non-BIS monitoring to guide propofol sedation in Endoscopic ULtrasound procedure: A prospective study

â??Propofol Induced Sedation with or without BIS Index monitoring during advanced Gastrointestinal Endoscopic Ultrasound- a Prospective Observational Studyâ??.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054958
Enrollment
60
Registered
2023-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Intervention1: BIS monitoring: BIS monitoring to guide depth of sedation in Endoscopic ultrasound procedures.

Sponsors

ILBS, new delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (18-70 years),ASA grade I -II undergoing EUS procedure at the Institute of Liver and Biliary Sciences(ILBS) New Delhi.

Exclusion criteria

Exclusion criteria: Patient refusal Chronic sedative or opioid analgesic use Known allergy to propofol Uncontrolled Hypertension Pregnant patients Cirrhosis

Design outcomes

Primary

MeasureTime frame
Comparison of incidence of desaturation during the EUS procedure each in BIS and non-BIS monitoring groups. Timepoint: At every 5 mins during the procedure till it is over—

Secondary

MeasureTime frame
Comparison of incidence of hypotension in both BIS and non-BIS groups Timepoint: At every 5 mins till end of procedure;comparison of incidence of apnea episodes in both the BIS nad non-BIS groups.Timepoint: At every 5 mins till procedure is over;comparison of incidence of arrythmia in both the groupsTimepoint: At every 5 mins till procedure is over;comparison of recovery time (Aldrete score8) in BIS vs non-BIS groups.Timepoint: At the end of procedure;comparison of total dose of propofol consumption in BIS vs non- BIS groupsTimepoint: At the end of procedure;operators satisfaction score as good, ok or difficult in BIS vs non-BIS groupsTimepoint: At the end of procedure—

Countries

India

Contacts

Public ContactPratyasha Nayak

Institute of Liver and Biliary Sciences, New Delhi

shivalipanwar@gmail.com9818241779

Outcome results

None listed

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