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NCT Number: NCT05473949

Ketofol Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients.

This study is a double blind randomized controlled trial. The investigators randomized ASA III and IV patients who underwent cholangiopancreatography. The investigators gave Propofol or Ketofol and compared the outcomes. The primary outcome was security (respiratory depression / hypoventilation).

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Randomization is performed by the nurse responsible for preparing the anesthesia drugs. The nurse randomly removes an envelope from a previously prepared container with as many envelopes as the number of patients calculated for the sample. Each envelope, which will be sealed, contains the branch to which the patient belongs (propofol or ketofol) and instructions for the preparation of the respective drugs.

The sample was calculated for a significance level of 5% and a test power of 95%, assuming that, on average, the primary outcome of this study - respiratory depression - is observed in 3% of the population undergoing sedation with ketofol and to 25% of patients undergoing sedation with propofol. The result of the calculation includes 51 patients for each branch of the study (considering the one-tailed hypothesis test).

Data collection is expected to take place over 5 months, taking place between October 2016 and March 2017.

The study is designed to be blinded to the patient and the anesthesiologist/investigator.

The anesthesia nurse, after preparing the drugs according to the instructions on the envelope containing the branch of the study to which the patient belongs, should label each syringe in a non-committal manner.

Statistical analysis was performed using the IBM SPSS Statistics 27.

It will not be necessary to resort to the monitoring committee, since no method or technique different from the one usually practiced will be applied

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old
  • ASA III and IV
  • Submitted to retrograde cholangiopancreatography

Exclusion criteria

  • Patient refuse
  • ASA I, II and V
  • Ketamine contraindications
  • Allergies to Propofol, Ketamine, dexamethasone, paracetamol, metamizole, ondanseteon or other.
  • General anesthesia necessary I
  • Incapacitaty to sign or absence of patient legal representation.

Treatment and study plan

Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients

Drug

Use of 1% Propofol (Indution dose: 0.75mg/kg Maintenance dose: 6-7mg/kg/h) for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients

Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients

Drug

use of Ketofol (1% Propofol + 5% Ketamine with a ratio 1/4) Indution dose: 0.75mg/kg Maintenance dose: 6-7mg/kg/h) for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients

Primary outcomes

  1. Security - Hypoventilation / Respiratory Depression

    Time frame: Intraprocedure

    Hypoventilation / Respiratory Depression defined as: Need for airway management (mandibular subluxation or other permeabilization maneuvers, use of adjuvants, need for assisted or controlled ventilation); Oxygen desaturation measured by pulse oximeter n(<95%); Apnea (>10 seconds)

Secondary outcomes

  1. Security - Intraprocedure hypotension

    Time frame: During the procedure and immediately after the end of procedure

    Intraprocedure hypotension defined as: non invasive arterial systolic pressure < 90 mmHg and/or diastolic < 60 mmHg OR non invasive arterial pressure < 20% of the base value

  2. Efficiency - Intraprocedure opioid necessity

    Time frame: During the procedure and immediately after the end of procedure

    Intraprocedure opioid necessity: Pain during the procedure, interpreted by the anesthesiologist through patient complaints or through analysis of hemodynamic parameters; Pain after the procedure, quantified by the visual analogue pain scale (VAS) 0-10, where 0 corresponds to no pain and 10 corresponds to the worst possible pain); Need for supplemental analgesia.

  3. Efficiency - Assessment of sedation level

    Time frame: During the procedure and immediately after the end of procedure

    Assessment of sedation level : the investigators measured the level of sedation for each participant with the Sedation Ramsay Scale.

  4. Quality - Patients satisfaction

    Time frame: At the end of the procedure (when the patient lucid and oriented in person, time and space) and 24 hours after the end of the procedure

    Patients satisfaction at the end of the procedure and after 24 hour: the investigators evalueted the patient satisfaction with a 4 point rating scale (1 - dissatisfied, 2- little satisfied, 3- satisfied, 4- very satisfied); and no opinion (NP). This evalution was perfomed after gaining consciousness (being oriented in the person, time and space) in the first two hours after the end of the procedure.

    The patient was contacted 24 hours after the end of the procedure (by phone or in person if still hospitalized) by one of the investigators, in order to assess the patient's well-being, degree of pain, occurrence of nausea or vomiting and satisfaction at the time. These data are recorded in a specific form, which again does not specify which branch of the study the patient was assigned to (blind to the investigator), and stored in a separate folder with the same numerical code assigned to the form completed the day before by the investigators.

  5. Quality - Gastroenterologist satisfaction

    Time frame: Immediately at the end of the procedure

    Gastroenterologist satisfaction: the investigators evalueted the Gastroenterologist satisfaction at the end of the procedure with a 4 point rating scale (1 - dissatisfied, 2- little satisfied, 3- satisfied, 4- very satisfied); and no opinion (NP).

  6. Quality - Occurrence of postoperative nausea or vomiting

    Time frame: In the first 24 hours after the end of the procedure

    Occurrence of postoperative nausea or vomiting: the investigators recorded the occurrence of nausea or vomiting after the procedure within the first 24 hours.

  7. Quality - Occurence of psychotomimetic effects

    Time frame: In the first 24 hours after the end of the procedure

    Occurence of psychotomimetic effects: the investigators recorded the occurrence of psychotomimetic effects after the procedure within the first 24 hours.

    The investigators verify the occurrence of the most frequent psychomimetic symptoms by questionnaire and medical/physical evaluation (anxiety, confusion, disorientation / psychomotor agitation, dysphoria, dissociative state and delirium with or without hallucinations, abnormal dreams, nightmares, insomnia)

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Universitário Lisboa Norte

Other

Registry information

Official study title

Ketofol (Ketamine and Propofol) Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2022
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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