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

NCT ID: NCT05473949

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2017-03-31

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

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Hospitalar Universitário Lisboa Norte

OTHER

Sponsor Role: lead

Responsible Party

Henrique Xavier Ornelas Gouveia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amélia Almeida

Role: STUDY_CHAIR

Centro Hospitalar e Universitário de Lisboa Norte

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: RESULT

PMID: 21237532 (View on PubMed)

Ronald D. Miller, Miller's Anesthesia, 7th edition, Section III - Anesthetic Pharmacology, Chapter 26: Intravenous Anesthetics, p. 724

Reference Type: RESULT

Other Identifiers

566/15

Identifier Type: -

Identifier Source: org_study_id