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

Anesthesia Clinical Trial

Official title:

Ketofol (Ketamine and Propofol) Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05473949
• Other study ID #: 566/15
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: August 2022
• Source: Centro Hospitalar Universitário Lisboa Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar Universitário Lisboa Norte

References & Publications (4)

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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Security - Intraprocedure hypotension	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	During the procedure and immediately after the end of procedure
Secondary	Efficiency - Intraprocedure opioid necessity	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.	During the procedure and immediately after the end of procedure
Secondary	Efficiency - Assessment of sedation level	Assessment of sedation level : the investigators measured the level of sedation for each participant with the Sedation Ramsay Scale.	During the procedure and immediately after the end of procedure
Secondary	Quality - Patients satisfaction	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.	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
Secondary	Quality - Gastroenterologist satisfaction	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).	Immediately at the end of the procedure
Secondary	Quality - Occurrence of postoperative nausea or vomiting	Occurrence of postoperative nausea or vomiting: the investigators recorded the occurrence of nausea or vomiting after the procedure within the first 24 hours.	In the first 24 hours after the end of the procedure
Secondary	Quality - Occurence of psychotomimetic effects	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)	In the first 24 hours after the end of the procedure