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History of Changes for Study: NCT05473949
Ketofol Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients.
Latest version (submitted August 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 23, 2022 None (earliest Version on record)
2 August 5, 2022 Study Status and Outcome Measures
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Study NCT05473949
Submitted Date:  July 23, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 566/15
Brief Title: Ketofol Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients.
Official Title: Ketofol (Ketamine and Propofol) Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2022
Overall Status: Completed
Study Start: October 1, 2016
Primary Completion: March 31, 2017 [Actual]
Study Completion: March 31, 2017 [Actual]
First Submitted: March 28, 2022
First Submitted that
Met QC Criteria:
July 23, 2022
First Posted: July 26, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
July 23, 2022
Last Update Posted: July 26, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Centro Hospitalar Universitário Lisboa Norte
Responsible Party: Principal Investigator
Investigator: Henrique Xavier Ornelas Gouveia
Official Title: Principal Investigator
Affiliation: Centro Hospitalar Universitário Lisboa Norte
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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

Open or close this module Conditions
Conditions: Anesthesia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 102 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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
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.

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
Open or close this module Outcome Measures
Primary Outcome Measures:
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 Outcome Measures:
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 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.

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)

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Study Officials: Amélia Almeida
Study Chair
Centro Hospitalar e Universitário de Lisboa Norte
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Approval from other investigators is required and research center approval - Centro Hospitalar e Universitário de Lisboa Norte
Open or close this module References
Citations: Standard for basis anesthetic monitoring - Committee of Origin: Standards and Practice Parameters; Approved by the ASA House of Delegates on October 21, 1986, and last amended on October 20, 2010 with an effective date of July 1, 2011
Statement on nonoperating room anesthetizing locations - Committee of origin: Standards and Practice Parameters; Approved by the ASA House of Delegates in October 19,1994, and last amended on October 16, 2013
[Study Results] Green SM, Andolfatto G, Krauss B. Ketofol for procedural sedation? Pro and con. Ann Emerg Med. 2011 May;57(5):444-8. doi: 10.1016/j.annemergmed.2010.12.009. Epub 2011 Jan 14. PubMed 21237532
[Study Results] Ronald D. Miller, Miller's Anesthesia, 7th edition, Section III - Anesthetic Pharmacology, Chapter 26: Intravenous Anesthetics, p. 724
Links:
Available IPD/Information:

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