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To compare Satisfaction and safety among patients and surgeons of using drug called Dexmedetomidine or Propofol for sedation in addition Ketamine during Endoscopic Retrograde Cholangiopancreatography by doing a Randomized control trial.

Satisfaction and safety using low dose Dexmedetomidine or Propofol sedation in addition to Ketamine during Endoscopic Retrograde Cholangiopancreatography: A Randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035358
Enrollment
80
Registered
2021-08-03
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: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine sedation in addition to Ketamine and Fentanyl: Dose of the â??Test Drugâ?? to be administered will be calculated as â?? Dexmedetomidine 0.4 mcg/kg/IV loading dose follow

Sponsors

Armed Forces Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists Physical Status (ASA PS) I to III and able to provide informed consent.

Exclusion criteria

Exclusion criteria: A known allergic reaction to planned medication A history of unregulated or malignant hypertension Significant ischemic heart disease Psychiatric disease Pregnancy Seizure disorders Increased intracranial pressure Substance abuse or use of drugs that affect the central nervous system.

Design outcomes

Primary

MeasureTime frame
To compare the patient and endoscopist satisfaction levels as primary objective which will be measured by Patient satisfaction with sedation instrument (PSSI) â?? 20 Items and Clinician satisfaction with sedation instrument (CSSI)-21 Items QuestionnaireTimepoint: Data will be collected 2 Hours after the procedure from patient and immediately after the procedure from the surgeon.—

Secondary

MeasureTime frame
â?¢Heart rate, Respiratory rate, oxygen saturation â?¢Systolic Blood Pressure, Mean arterial Pressure, Diastolic Blood Pressure â?¢Bispectral Index Monitoring (BIS Monitoring) during and after surgeryTimepoint: Three Baseline readings of HR, RR, SPO2, SBP, MAP ,DBP and BIS Monitoring will be taken before the procedure and a mean of it will be calculated. During procedure HR, RR, SPO2, SBP, MAP , DBP and BIS Monitoring will be recorded at five minute interval during procedure and after procedure two readings will be taken at a 15 minute interval and three more readings at a 30 minutes interval thereby monitoring for 2 hours after procedure.—

Countries

India

Contacts

Public ContactDr B Srinivas Naik

Armed Forces Medical College

drsinghafmc@gmail.com9968619883

Outcome results

None listed

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