Dexmedetomidine Versus Ketofol for Moderate Sedation in Endoscopic Retrograde Cholangiopancreatography

January 15, 2024 updated by: Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation

Comparison of Dexmedetomidine Versus Ketofol For Moderate Sedation In Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Controlled Trial

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".

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients aged 20-60 years of any gender scheduled for elective ERCP were included. All these patients had American Society of Anesthesiologists (ASA) classification I or II. While those who were allergic to dexmedetomidine, Ketofol, or related medications, BMI over 36 kg/m2 (morbidly obese), had a history of stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, hypothyroidism, and congestive cardiac failure were excluded. Furthermore, pregnant, or breastfeeding women or patients who reported chronic use of sedative medications or substance abuse, known contraindications to ERCP, and already enrolled in another clinical trial study were excluded.

Patients were randomly divided into two groups using computer randomization. All patients were taken to the procedure room and venous access was secured on a non-dominant hand by 20G IV cannula, intravenous (I/V) fluid (ringer lactate or normal saline) was started by 8 ml/kg/h, and oxygen support was provided by nasal cannula at 4 liters per minute. Standard monitors were attached for heart rate (HR), noninvasive blood pressure (systolic and diastolic), mean arterial blood pressure (MAP), and peripheral oxygen saturation SpO2. Injection midazolam 0.05 mg/kg was also given I/V to every patient in both groups to decrease the anxiety of patients.

Patients received either Dexmedetomidine or Ketofol for sedation. All syringes and infusion sets were covered by silver paper and these infusions were labeled as infusion 1 or 2. 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".

During infusion, vitals were recorded at 0,1,3,5, and 10-minute intervals from the start, and the Ramsay Sedation scale score (RSS) was recorded every 1 minute. Both infusions were started as per the randomization of groups. The mean difference in time to achieve adequate sedation and time to good recovery were noted as outcomes in each group. In addition, complications during the procedure and recovery were also noted. Adequate sedation was defined as the time from initiation of infusion to achieve an RSS score of 4. While Modified Aldrete's score (MAS) was used to assess the recovery. Time from discontinuation of the infusion to achieve an MAS score of 9 was labeled as a good recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Sindh Institute of Urology and Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dexmedetomidine
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
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
Active Comparator: Ketofol
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
Patients received ketofol 1mg/kg over 10 minutes followed by 50ug/kg/min of infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ramsay sedation score
Time Frame: 0-2 hours

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Aldrete's score
Time Frame: 10-15 minutes

Modified Aldrete's Score, also known as the Aldrete Score, consists of five criteria, each scored from 0 to 2, with a maximum total score of 10. The criteria are:

  1. Activity
  2. Respiration
  3. Circulation
  4. Consciousness

  5. Oxygen Saturation

    • A score of 9-10 indicates the patient is ready for discharge from the recovery area.
    • A score of 8 may be acceptable for discharge based on the surgeon's and anesthetist's discretion.
    • Scores below 8 may necessitate further observation and interventions.
10-15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sindh Institute of Urology and Transplantation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Syed M Abbas, FCPS, Sindh Institute of Urology and Transplantation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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