Procedural SedationPhase 1/2NCT04686448
Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release
A Phase 1/2 study testing propofol-ketamine and propofol-fentanyl in people with Procedural Sedation, run by Zagazig University at 1 site in Egypt.
Trial summary
There are different methods of anesthesia for CTR surgery. Procedural sedation will allow rapid recovery and fewer complications than regional or general anesthesia (GA). Attempts have been made in the past to use additives with propofol to reduce its dose. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- propofol-ketamine and propofol-fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 May 2021
- Phase
- Phase 1/2
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 21-55 years old.
- Sex: both sex (males or females).
- Physical status: ASA I \& II.
- BMI: 25-30 kg/m2.
- Type of operation: elective unilateral CTR under local anesthesia.
- Written informed consent from the patient.
- Cooperative patient.
Who cannot join
- Patient refusal.
- Altered mental status.
- Patients with known history of allergy to study drugs.
- Severe hepatic, renal, Cardiovascular and respiratory diseases.
- Patients on regular sedative or pain killer medications.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig
Marwa Zakzouk, MD, 01004178761 ext. 002, dr.marwa.zu@gmail.com
Alshaimaa Kamel, MD, 01005593169 ext. 002, Alshaimaakamel80@yahoo.com
About this study
Official title: Propofol-Ketamine (Ketofol) Versus Propofol-Fentanyl (Fenofol) as Procedural Sedation for Unilateral Open Carpal Tunnel Release Under Local Anesthesia
There are different methods of anesthesia for CTR surgery. Procedural sedation will allow rapid recovery and fewer complications than regional or general anesthesia (GA).
Attempts have been made in the past to use additives with propofol to reduce its dose. Ketofol (ketamine/propofol combination) was used for procedural sedation and analgesia. Ketamine and propofol administered in combination have offered effective sedation for spinal anesthesia and for gynecologic, ophthalmologic, and cardiovascular procedures in all age groups. The opposing hemodynamic and respiratory effects of each drug may enhance the utility of this drug combination, increasing both safety and efficacy and allowing reduction in the dose of propofol required to achieve sedation.
Propofol alone had a significantly greater number of apnea with desaturation (SpO2 < 90%) episodes. Further, it has been shown that during colonoscopies, propofol in combination with fentanyl provided similar patient satisfaction with shorter recovery times even at lower depths of sedation as compared to propofol. The addition of fentanyl to propofol has been shown to result in better operator feasibility with no difference in recovery time, cognitive impairment, or complications as compared to the use of propofol only for sedation.
Read the detailed description
Sample size: assuming that the sedation using modified Ramasy sedation score was 6±0.01 in ketofol group versus 5.38±0.87 in fenofol group so the sample will be 56 patients, 28 patients in each group using OPENEPI at power 80 and CI 95 A computer-generated randomization table divided patients into 2 equal groups.
- Group (K) (n=28): patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.
- Group (F) (n=28): patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.
The depth of sedation will be assessed by modified Ramsay sedation
- Conditions
- Procedural Sedation
- Being tested
- propofol-ketamine, propofol-fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol-ketamineDrug
Also called ketofol
patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4
propofol-fentanylDrug
Also called fenofol
patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4
| Study group | Role | What they receive |
|---|---|---|
| propofol-ketamine | Active comparator | patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4 Receives: Drug: propofol-ketamine |
| propofol-fentanyl | Active comparator | patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4 Receives: Drug: propofol-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
depth of sedation
assessed by Modified Ramsay sedation scale. Score Modified Ramsay Sedation Scale Score
- Awake and alert, minimal or no cognitive impairment
- Awake but tranquil, purposeful responses to verbal commands at conversational level
- Appears asleep, purposeful responses to verbal commands at conversational level
- Appears asleep, purposeful responses to verbal commands but at louder than usual conversational level, requiring light glabellar tap, or both
- Asleep, sluggish purposeful responses only to loud verbal commands, strong glabellar tap, or both
- Asleep, sluggish purposeful responses only to painful Stimuli
- Asleep, reflex withdrawal to painful stimuli only (no purposeful responses)
- Unresponsive to external stimuli, including pain interpretation: score 1= minimal sedation score 2-4=moderate sedation score 5-7=deep sedation score 8=anesthesia
Measured: from drug injection up to 15 minutes till modified Ramsay sedation scale ≤ 4
Secondary outcomes (5)
recovery time
The time from discontinuation of infusion drug to first response to verbal command
Measured: up to 30 minutes postoperative
• The total duration of post-anesthesia care unit (PACU) stay (The time from arrival to the PACU to discharge to the ward) according to modified Aldrete score 9
Modified Aldert score. Assessment items Condition Grade Activity, able to move, voluntarily or on command 4 extremities 2 2 extremities 1 No 0
Breathing Able to breathe deeply \& cough freely 2 Dyspnea, shallow or limited breathing 1 Apnea 0
Consciousness Fully awake 2 Arousable on calling 1 Unresponsive 0 Circulation (BP) ±20% of pre-anesthesia level 2
- 20% to 49% of pre-anesthesia level 1
- 50% of pre-anesthesia level 0
SPO2 Maintains SpO2 >92% in ambient air 2 Maintain SpO2 >90% with O2 1 Maintain SpO2 <90% with O2 0
- Patient having a score of 9 or higher is discharged
Measured: up to 1 hour postoperative
Total propofol consumption by mg
intraoperatice total propofol consumption by mg
Measured: from the start of drug injection till discontinuation of propfol infusion about 1 hour
number of participants with intraoperative complications such as hypotenstion, bradycardia and hypoxia
Intraoperative Complications such as hypotension (a decrease in mean arterial pressure 20% from base line mean arterial pressure, it will be treated with intravenous fluids and incremental doses of ephedrine), bradycardia (a decrease in heart rate 20% from base line heart rate, it will be treated with atropine) and hypoxia (a decrease in O2 saturation below 92%) will be treated with increasing O2 flow
Measured: from the start of drug injection till end of surgery about 1 hour
number of participants with postoperative complications such as postoperative nausea and vomting
number of participants with postoperative complications such as postoperative nausea and vomting
Measured: within 12 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mahmoud Abd Allah Zakzouk, Zagazig University
- Investigators
- Marwa Zakzouk, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686448
- Sponsor's protocol ID
- 6556
- Status last verified
- Feb 2021
- First submitted
- 22 Dec 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol-Ketamine (Ketofol) Versus Propofol-Fentanyl (Fenofol) as Procedural Sedation for Unilateral Open Carpal Tunnel Release Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT04686448
- Acronym / sponsor ID
- 6556
- Conditions
- Procedural Sedation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 28 Dec 2020 (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.
There are different methods of anesthesia for CTR surgery. Procedural sedation will allow rapid recovery and fewer complications than regional or general anesthesia (GA).
Attempts have been made in the past to use additives with propofol to reduce its dose. Ketofol (ketamine/propofol combination) was used for procedural sedation and analgesia. Ketamine and propofol administered in combination have offered effective sedation for spinal anesthesia and for gynecologic, ophthalmologic, and cardiovascular procedures in all age groups. The opposing hemodynamic and respiratory effects of each drug may enhance the utility of this drug combination, increasing both safety and efficacy and allowing reduction in the dose of propofol required to achieve sedation.
Propofol alone had a significantly greater number of apnea with desaturation (SpO2 < 90%) episodes. Further, it has been shown that during colonoscopies, propofol in combination with fentanyl provided similar patient satisfaction with shorter recovery times even at lower depths of sedation as compared to propofol. The addition of fentanyl to propofol has been shown to result in better operator feasibility with no difference in recovery time, cognitive impairment, or complications as compared to the use of propofol only for sedation.
Detailed description
Sample size: assuming that the sedation using modified Ramasy sedation score was 6±0.01 in ketofol group versus 5.38±0.87 in fenofol group so the sample will be 56 patients, 28 patients in each group using OPENEPI at power 80 and CI 95 A computer-generated randomization table divided patients into 2 equal groups.
- Group (K) (n=28): patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.
- Group (F) (n=28): patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.
The depth of sedation will be assessed by modified Ramsay sedation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol-ketamine | Active comparator | Drug: propofol-ketaminepatients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4 |
| propofol-fentanyl | Active comparator | Drug: propofol-fentanylpatients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 21-55 years old.
- Sex: both sex (males or females).
- Physical status: ASA I \& II.
- BMI: 25-30 kg/m2.
- Type of operation: elective unilateral CTR under local anesthesia.
Key exclusion criteria (5 listed)
- Patient refusal.
- Altered mental status.
- Patients with known history of allergy to study drugs.
- Severe hepatic, renal, Cardiovascular and respiratory diseases.
- Patients on regular sedative or pain killer medications.
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 |
|---|---|---|
| propofol-ketamineAlso: ketofolpatients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4 | Drug | propofol-ketamine |
| propofol-fentanylAlso: fenofolpatients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4 | Drug | propofol-fentanyl |
Primary outcome
depth of sedation
Time frame: from drug injection up to 15 minutes till modified Ramsay sedation scale ≤ 4
assessed by Modified Ramsay sedation scale. Score Modified Ramsay Sedation Scale Score 1. Awake and alert, minimal or no cognitive impairment 2. Awake but tranquil, purposeful responses to verbal commands at conversational level 3. Appears asleep, purposeful responses to verbal commands at conversational level 4. Appears asleep, purposeful responses to verbal commands but at louder than usual conversational level, requiring light glabellar tap, or both 5. Asleep, sluggish purposeful responses only to loud verbal commands, strong glabellar tap, or both 6. Asleep, sluggish purposeful responses only to painful Stimuli 7. Asleep, reflex withdrawal to painful stimuli only (no purposeful responses) 8. Unresponsive to external stimuli, including pain interpretation: score 1= minimal sedation score 2-4=moderate sedation score 5-7=deep sedation score 8=anesthesia
5 secondary outcomes
recovery time
Time frame: up to 30 minutes postoperative
• The total duration of post-anesthesia care unit (PACU) stay (The time from arrival to the PACU to discharge to the ward) according to modified Aldrete score 9
Time frame: up to 1 hour postoperative
Total propofol consumption by mg
Time frame: from the start of drug injection till discontinuation of propfol infusion about 1 hour
number of participants with intraoperative complications such as hypotenstion, bradycardia and hypoxia
Time frame: from the start of drug injection till end of surgery about 1 hour
number of participants with postoperative complications such as postoperative nausea and vomting
Time frame: within 12 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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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.
Marwa Zakzouk, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing propofol-ketamine and propofol-fentanyl in people with Procedural Sedation, run by Zagazig University at 1 site in Egypt.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Zakzouk, MD (01004178761 ext. 002, dr.marwa.zu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depth of sedation (time frame: from drug injection up to 15 minutes till modified Ramsay sedation scale ≤ 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2021.