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Improving Sedation For Endoscopy Of Biliary Tract: Testing A Two-Drug Combination Using Brain Wave Monitoring.

Effect Of Dexmedetomidine On Target Plasma Concentration Of Propofol For Bispectral Index (BIS) -Guided Sedation During Endoscopic Retrograde Cholangiopancreatography - A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100400
Enrollment
90
Registered
2026-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K831- Obstruction of bile duct

Interventions

Intervention1: Propofol Infusion Along with Dexmedetomidine Bolus And Infusion at 0.25 mcg/kg/hour. : Patient Undergoing ERCP Will be Given Sedation With Propofol And Dexmedetomidine Both. Propofol I

Sponsors

INSTITUTE OF LIVER AND BILIARY SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Patients Undergoing ERCP and Belonging To American Society of Anesthesiologist Physical Status 1 and 2.

Exclusion criteria

Exclusion criteria: Patient Refusal, Allergy To Propofol Or Dexmedetomidine, Anticipated Difficult Airway, Obesity With Bmi More Than 40, Baseline Severe Bradycardia (Hr Less Than 50/ Min), Decompensated Liver Disease Belonging To Child B And Child C Status, Uncontrolled Hypotension (Mean Arterial Pressure Less Than 65 Mmhg Despite Fluids/pressors),American Society of Anesthesiologist Physical Status 3 and 4, Pregnant Females.

Design outcomes

Primary

MeasureTime frame
To Determine Mean Target Plasma Propofol Concentration (CP) Required To Maintain Bispectral Index Value Of 60 70 While Using Combined Propofol Target Controlled Infusion (Marsh) Plus Dexmedetomidine Infusion With Two Different Dosages Of Dexmedetomidine During Ercp. Timepoint: At The End of ERCP (After Averaging All The Values Taken During The Procedure Every 5 Mins)

Secondary

MeasureTime frame
Time to achieve target BIS value of 60- 70 across three groups. Timepoint: At the begining of ERCP;To compare the incidence of hypotension, bradycardia, desaturation, respiratory depression and apnea across three groups.Timepoint: During the procedure and till recovery;To compare time to achieve BIS of 80 after stopping of infusions and time to clinical recovery based on Modified observer assessment of alertness/sedation scale.Timepoint: During the procedure and till recovery;To compare endoscopist satisfaction score across three groups.Timepoint: At the end of ERCP;To compare propofol consumption across three groups.Timepoint: At the end of ERCP

Countries

India

Contacts

Public ContactSURAJ VERMA

Institute of Liver and Biliary Sciences

uddh1989@gmail.com8861987684

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026