AnesthesiaNCT05473949
Ketofol Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients.
A study testing Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients and Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients in people with Anesthesia, run by Centro Hospitalar Universitário Lisboa Norte.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients and Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old
- ASA III and IV
- Submitted to retrograde cholangiopancreatography
Who cannot join
- 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.
About this study
Official title: Ketofol (Ketamine and Propofol) Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
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).
Read the 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
- Being tested
- Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients, Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV PatientsDrug
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 PatientsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Intraprocedure
Secondary outcomes (7)
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
Measured: During the procedure and immediately after the end of procedure
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.
Measured: During the procedure and immediately after the end of procedure
Efficiency - Assessment of sedation level
Assessment of sedation level : the investigators measured the level of sedation for each participant with the Sedation Ramsay Scale.
Measured: During the procedure and immediately after the end of procedure
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.
Measured: 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
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).
Measured: Immediately at the end of the procedure
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.
Measured: In the first 24 hours after the end of the procedure
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)
Measured: In the first 24 hours after the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Oct 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitário Lisboa Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrique Xavier Ornelas Gouveia, Centro Hospitalar Universitário Lisboa Norte
- Investigators
- Amélia Almeida, Study chair, Centro Hospitalar e Universitário de Lisboa Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473949
- Sponsor's protocol ID
- 566/15
- Status last verified
- Aug 2022
- First submitted
- 28 Mar 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Approval from other investigators is required and research center approval - Centro Hospitalar e Universitário de Lisboa Norte
Publications
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
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.
PubMed 21237532Ronald D. Miller, Miller's Anesthesia, 7th edition, Section III - Anesthetic Pharmacology, Chapter 26: Intravenous Anesthetics, p. 724
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketofol (Ketamine and Propofol) Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
- ClinicalTrials.gov ID
- NCT05473949
- Acronym / sponsor ID
- 566/15
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centro Hospitalar Universitário Lisboa NorteUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV PatientsASA 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. |
| Ketofol | Active comparator | Drug: Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients2. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old
- ASA III and IV
- Submitted to retrograde cholangiopancreatography
Key exclusion criteria (6 listed)
- Patient refuse
- ASA I, II and V
- Ketamine contraindications
- Allergies to Propofol, Ketamine, dexamethasone, paracetamol, metamizole, ondanseteon or other.
- General anesthesia necessary I
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV PatientsUse 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 | Drug | Propofol |
| Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patientsuse 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 | Drug | Ketofol |
Primary outcome
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)
7 secondary outcomes
Security - Intraprocedure hypotension
Time frame: During the procedure and immediately after the end of procedure
Efficiency - Intraprocedure opioid necessity
Time frame: During the procedure and immediately after the end of procedure
Efficiency - Assessment of sedation level
Time frame: During the procedure and immediately after the end of procedure
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
Quality - Gastroenterologist satisfaction
Time frame: Immediately at the end of the procedure
Quality - Occurrence of postoperative nausea or vomiting
Time frame: In the first 24 hours after the end of the procedure
Quality - Occurence of psychotomimetic effects
Time frame: In the first 24 hours after the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- BackgroundStandard 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
- BackgroundStatement 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
- Results publication: PubMed 21237532Green 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.
- Results publicationRonald D. Miller, Miller's Anesthesia, 7th edition, Section III - Anesthetic Pharmacology, Chapter 26: Intravenous Anesthetics, p. 724
- Individual participant dataSharing planned: No. Approval from other investigators is required and research center approval - Centro Hospitalar e Universitário de Lisboa Norte
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amélia Almeida study chair
Centro Hospitalar e Universitário de Lisboa Norte
Questions about this trial
What is this clinical trial studying?
A study testing Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients and Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients in people with Anesthesia, run by Centro Hospitalar Universitário Lisboa Norte.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Security - Hypoventilation / Respiratory Depression (time frame: Intraprocedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473949, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.