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

NCT05473949 | Completed

• 1 other identifier: 566/15
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Security - Hypoventilation / Respiratory Depression

  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)

  Intraprocedure

Secondary Outcomes (7)

• Security - Intraprocedure hypotension

  During the procedure and immediately after the end of procedure

• Efficiency - Intraprocedure opioid necessity

  During the procedure and immediately after the end of procedure

• Efficiency - Assessment of sedation level

  During the procedure and immediately after the end of procedure

• Quality - Patients satisfaction

  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

• Quality - Gastroenterologist satisfaction

  Immediately at the end of the procedure

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Ketofol

ACTIVE COMPARATOR

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

Interventions

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

Propofol

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

Ketofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar Universitário Lisboa Norte: lead

Related Publications (4)

• 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

  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

  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.

  PMID: 21237532 RESULT

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

  RESULT

Study Officials

• Amélia Almeida

  Centro Hospitalar e Universitário de Lisboa Norte

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: July 26, 2022
• Study Start: October 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share