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

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ClinicalTrials.gov Identifier: NCT05473949
Recruitment Status : Completed
First Posted : July 26, 2022
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Henrique Xavier Ornelas Gouveia, Centro Hospitalar Universitário Lisboa Norte

Tracking Information
First Submitted Date  ICMJE March 28, 2022
First Posted Date  ICMJE July 26, 2022
Last Update Posted Date August 9, 2022
Actual Study Start Date  ICMJE October 1, 2016
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2022)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2022)
  • 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
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2022)
  • 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
  • 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.
  • 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.
  • 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 at the end of the procedure after gaining consciousness (being oriented in the person, time and space). 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.
  • 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).
  • 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.
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketofol Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients.
Official Title  ICMJE Ketofol (Ketamine and Propofol) Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
Brief Summary 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).
Detailed Description

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
    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
  • Drug: Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
    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
Study Arms  ICMJE
  • Active Comparator: Propofol

    ASA Standard monitorization and nasal spectacle capnography (OC) were used. Supplementary supply of O2 is placed at 2-3 L/min also by OC.

    The drugs were randomized of the study begins. The investigators didn't know whether ketamine is present in syringes prepared with propofol or not, acting in the same way for both drug combinations.

    Sedation was performed with:

    1. Propofol: induction with a bolus of 1% propofol (10mL syringe) administered at a dose of 0.75mg/kg; maintenance with 1% propofol infusion (20mL syringe), at an infusion rate of 6-7mg/kg/h.

    In both arms:

    • 4 mg of I.V. dexamethasone were administered.
    • At the beginning of the procedure and atropine and ephedrine were prepared.
    • At the end of the procedure, paracetamol I.V. 15mg/kg was administered.
    • If the patient reports VAS>3 pain in recovery, metamizole magnesium 15mg/kg is also administered.
    • In case of post-procedure nausea and/or vomiting, 4 mg of ondansetron would be administered as a rescue.
    Intervention: Drug: Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
  • Active Comparator: Ketofol

    2. Sedation with ketofol in a 1:4 dilution: induction of sedation with bolus of ketofol (dilution containing 9.5 mL of 1% propofol + 0.5 mL of 5% ketamine) (10mL syringe), administered at a dose of 0.75 mg/kg; maintenance with ketofol infusion (dilution containing 19 mL of 1% Propofol + 1 mL of 5% Ketamine), (20mL syringe), at an infusion rate of 6-7mg/kg/h.

    The dose used for bolus induction of sedation in both arms of the study is titrated to the needs of each individual patient, although the target approximates the usual recommended dose. If a propofol or ketofol syringe is insufficient considering the patient's weight, another syringe will be prepared with exactly the same dilution as the first.

    The study was always blind to the investigators.

    Intervention: Drug: Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2022)
102
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05473949
Other Study ID Numbers  ICMJE 566/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Approval from other investigators is required and research center approval - Centro Hospitalar e Universitário de Lisboa Norte
Current Responsible Party Henrique Xavier Ornelas Gouveia, Centro Hospitalar Universitário Lisboa Norte
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centro Hospitalar Universitário Lisboa Norte
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Amélia Almeida Centro Hospitalar e Universitário de Lisboa Norte
PRS Account Centro Hospitalar Universitário Lisboa Norte
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP