Clinical trial NCT05473949: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Centro Hospitalar Universitário Lisboa Norte
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility 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.

Primary outcomes:
measure: Security - Hypoventilation / Respiratory Depression
timeFrame: Intraprocedure
Secondary outcomes:
measure: Security - Intraprocedure hypotension
timeFrame: During the procedure and immediately after the end of procedure
measure: Efficiency - Intraprocedure opioid necessity
timeFrame: During the procedure and immediately after the end of procedure
measure: Efficiency - Assessment of sedation level
timeFrame: During the procedure and immediately after the end of procedure
measure: Quality - Patients satisfaction
timeFrame: 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
measure: Quality - Gastroenterologist satisfaction
timeFrame: Immediately at the end of the procedure
measure: Quality - Occurrence of postoperative nausea or vomiting
timeFrame: In the first 24 hours after the end of the procedure
measure: Quality - Occurence of psychotomimetic effects
timeFrame: In the first 24 hours after the end of the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Centro Hospitalar e Universitário de Lisboa Norte
name: Amélia Almeida
role: STUDY_CHAIR
References:
citation: 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
citation: 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
citation: 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. No abstract available.
citation: Ronald D. Miller, Miller's Anesthesia, 7th edition, Section III - Anesthetic Pharmacology, Chapter 26: Intravenous Anesthetics, p. 724