AnesthesiaNCT04473846
Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures.
A study testing PK general anesthesia and PFK combination in people with Anesthesia, run by University of Jordan at 1 site in Jordan.
Trial summary
Conscious sedation provides adequate control of pain and anxiety for the majority of routine endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while others prefer using deep sedation or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- PK general anesthesia and PFK combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJordan
- Study dates
- Aug 2020to Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who were admitted for endoscopic and colonoscopic procedures.
- ASA (American Society of Anaesthesiologists physical status) score from 1 to 3.
Who cannot join
- patient refusal.
- urgent and emergency cases, which were not elective procedures.
- Surgeries that were expected to take a long duration (more than 1.5 hour).
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Jordan University Hospital
Amman, 13046
Shawqi Saleh, +962795577922, sssaleh@hotmail.com
Noor Rammadan, +962796234137, nm_rammadan@yahoo.com
About this study
Official title: The Use of Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures: a Prospective Study
Conscious sedation provides adequate control of pain and anxiety for the majority of routine endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while others prefer using deep sedation or general anaesthesia for colonoscopy. However, many physicians are still using moderate sedation for the majority of patients.
The use of propofol, a short acting anesthetic agent, for conscious sedation provides a considerably more rapid onset of action and shorter recovery time, for which it is believed to be a safe drug of choice for patients undergoing endoscopic procedures. Although propofol cannot be used as a single agent for moderate sedation, it can be effectively titrated to moderate sedation after administration of small doses of narcotics and sedatives.
The aim of this study is to compare between general anesthesia and deep sedation using propofol-fentanyl-ketamine (PFK) preparation in terms of perioperative vital signs, intraoperative awareness, post-operative pain scores, and the use of analgesia postoperatively.
- Conditions
- Anesthesia
- Being tested
- PK general anesthesia, PFK combination
- Keywords
- Anesthesia, Endoscopy, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK general anesthesiaDrug
Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).
PFK combinationDrug
Each patient received an initial dose of 0.05 ml/kg from the solution, then after waiting for 60 seconds, another 0.05 ml/kg were given. Maintenance was given as boluses of 0.025 ml/kg every three to five minutes.
| Study group | Role | What they receive |
|---|---|---|
| PF group | Experimental | The first group will undergo general anesthesia using Fentanyl and Propofol. Receives: Drug: PK general anesthesia |
| PFK group | Experimental | The second group will receive a mixture that consists of Fentanyl, Propofol, and Ketamine. In addition, Lidocaine will be added to reduce the pain on injection caused by Propofol. Receives: Drug: PFK combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transient decrease in oxygen saturation
the investigators will record any episodes of transient reduction of oxygen saturation.
Measured: 1 hour
Blood pressure stability
the investigators will record changes in blood pressure after induction of anesthesia
Measured: 1 hour
Recovery time
the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelkarim Saleh AlOweidi, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473846
- Sponsor's protocol ID
- 67/2020/524
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures: a Prospective Study
- ClinicalTrials.gov ID
- NCT04473846
- Acronym / sponsor ID
- 67/2020/524
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Endoscopy, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Jul 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.
Conscious sedation provides adequate control of pain and anxiety for the majority of routine endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while others prefer using deep sedation or general anaesthesia for colonoscopy. However, many physicians are still using moderate sedation for the majority of patients.
The use of propofol, a short acting anesthetic agent, for conscious sedation provides a considerably more rapid onset of action and shorter recovery time, for which it is believed to be a safe drug of choice for patients undergoing endoscopic procedures. Although propofol cannot be used as a single agent for moderate sedation, it can be effectively titrated to moderate sedation after administration of small doses of narcotics and sedatives.
The aim of this study is to compare between general anesthesia and deep sedation using propofol-fentanyl-ketamine (PFK) preparation in terms of perioperative vital signs, intraoperative awareness, post-operative pain scores, and the use of analgesia postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF group | Experimental | Drug: PK general anesthesiaThe first group will undergo general anesthesia using Fentanyl and Propofol. |
| PFK group | Experimental | Drug: PFK combinationThe second group will receive a mixture that consists of Fentanyl, Propofol, and Ketamine. In addition, Lidocaine will be added to reduce the pain on injection caused by Propofol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who were admitted for endoscopic and colonoscopic procedures.
- ASA (American Society of Anaesthesiologists physical status) score from 1 to 3.
Key exclusion criteria (3 listed)
- patient refusal.
- urgent and emergency cases, which were not elective procedures.
- Surgeries that were expected to take a long duration (more than 1.5 hour).
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 |
|---|---|---|
| PK general anesthesiaPatients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg). | Drug | PF group |
| PFK combinationEach patient received an initial dose of 0.05 ml/kg from the solution, then after waiting for 60 seconds, another 0.05 ml/kg were given. Maintenance was given as boluses of 0.025 ml/kg every three to five minutes. | Drug | PFK group |
Primary outcome
Transient decrease in oxygen saturation
Time frame: 1 hour
the investigators will record any episodes of transient reduction of oxygen saturation.
Blood pressure stability
Time frame: 1 hour
the investigators will record changes in blood pressure after induction of anesthesia
Recovery time
Time frame: 2 hours
the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PK general anesthesia and PFK combination in people with Anesthesia, run by University of Jordan at 1 site in Jordan.
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 2 inclusion and 3 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 16 Jul 2020. 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 Jordan. 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.
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 Abdelkarim S AlOweidi (+962795712121, akaloweidi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transient decrease in oxygen saturation (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 16 Jul 2020; AzTrials last refreshed its copy on 2 Nov 2026.