Dexmedetomidine Versus Ketofol for Moderate Sedation in Endoscopic Retrograde Cholangiopancreatography

NCT06212401 | Completed Phase 4 DMC

• 1 other identifier: 234
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Patients were randomly divided into Dexmedetomidine or Ketofol for sedation. In patients who received Dexmedetomidine, a 2ml ampule of 100 ug/ml was diluted in 18 ml of normal saline, making a total volume of 20 ml. Patients received dexmedetomidine as a bolus over 10 minutes in a dose of 1ug/kg followed by an infusion at the rate of 0.5ug/kg/hr and it was labeled as "infusion 1". In the Ketofol group, 2 ml ketamine (50mg/ml) and 10 ml of propofol 1% (10mg/ml) were diluted in 8ml of normal saline. This mixture was 20 ml each, making 5mg/ml of ketamine and propofol. Patients received 1mg/kg over 10 minutes followed by 50ug/kg/min of infusion, labeled as "infusion 2".

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• Ramsay sedation score

  Clinical Score Patient's Characteristics 1. Awake; agitated or restless or both 2. Awake; cooperative, oriented, and tranquil 3. Awake but responds to commands only 4. Asleep; brisk response to light glabellar tap or loud auditory stimulus 5. Asleep; sluggish response to light glabellar tap or loud auditory stimulus 6. Asleep; no response to glabellar tap or loud auditory stimulus

  0-2 hours

Secondary Outcomes (1)

• Modified Aldrete's score

  10-15 minutes

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine in a 2 ml ampule of 100 ug/ml diluted in 18 ml of normal saline, making a total volume of 20 ml.

Drug: Dexmedetomidine

Ketofol

ACTIVE COMPARATOR

2 ml ketamine (50mg/ml) and 10 ml of propofol 1% (10mg/ml) diluted in 8 ml of normal saline. This mixture was 20 ml each, making 5mg/ml of ketamine and propofol.

Drug: Ketofole

Interventions

Dexmedetomidine DRUG

Patients received dexmedetomidine as a bolus over 10 minutes in a dose of 1ug/kg followed by an infusion at the rate of 0.5ug/kg/hr

Dexmedetomidine

Ketofole DRUG

Patients received ketofol 1mg/kg over 10 minutes followed by 50ug/kg/min of infusion

Ketofol

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 20-60 years
• Any gender
• Scheduled for elective ERCP
• American Society of Anesthesiologists (ASA) classification I or II

You may not qualify if:

• Allergic to dexmedetomidine, Ketofol, or related medications
• BMI over 36 kg/m2 (morbidly obese)
• History of stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, hypothyroidism, and congestive cardiac failure

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Syed M Abbas, FCPS

  Sindh Institute of Urology and Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 18, 2024
• Study Start: December 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)