AnesthesiaNCT03806374
Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?
A study testing Ketamine, Propofol and Fentanyl in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as regards hemodynamics and smooth intubation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Ketamine, Propofol and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2018to 10 Dec 2018
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and II between
- Age between 18-55 years
- Undergoing minor surgical procedure less than an hour.
Who cannot join
- Patients with hypertension
- Patients with Ischemic heart diseases
- Patients with chronic renal or liver diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is it Possible to Replace Fentanyl by Non Narcotic Medication for Induction and Maintenance of Anesthesia in Minor Procedures?
To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as regards hemodynamics and smooth intubation.
Read the detailed description
Two groups each with 60 patients Group I anesthesia initiated by propofol, fentanyl and cisatracurium. Group II anesthesia initiated by ketamine, lidocaine, propofol and cisatracurium.
- Conditions
- Anesthesia
- Keywords
- fentanyl, lidocaine, ketamine, induction of anesthesia, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
ketamine
PropofolDrug
propofol
FentanylDrug
fentanyl
CisatracuriumDrug
cisatracurium
LidocaineDrug
lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Active comparator | Administered propofol and fentanyl for induction. Receives: Drug: Propofol; Drug: Fentanyl; Drug: Cisatracurium |
| Ketamine and lidocaine | Active comparator | Administered propofol, ketamine and lidocaine for induction. Receives: Drug: Ketamine; Drug: Propofol; Drug: Cisatracurium; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation with less hemodynamic changes
changes in blood pressure with intubation
Measured: 15 minutes after induction of anesthesia.
Smooth Maintenance of anesthesia
changes in blood pressure during anesthesia
Measured: anesthesia time
less postoperative pain killers
amount of pain killers used and timing
Measured: 24 hours postoperative
Intubation with less hemodynamic changes
changes in pulse rate during anesthesia
Measured: Anesthesia time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start2 Jan 2018
- Primary completion1 Dec 2018
- Study completion10 Dec 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Anis Metry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806374
- Sponsor's protocol ID
- ASUH9418
- Status last verified
- Jan 2019
- First submitted
- 11 Dec 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible to Replace Fentanyl by Non Narcotic Medication for Induction and Maintenance of Anesthesia in Minor Procedures?
- ClinicalTrials.gov ID
- NCT03806374
- Acronym / sponsor ID
- ASUH9418
- Conditions
- Anesthesia
- Keywords
- fentanyl, lidocaine, ketamine, induction of anesthesia, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 16 Jan 2019 (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.
To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as regards hemodynamics and smooth intubation.
Detailed description
Two groups each with 60 patients Group I anesthesia initiated by propofol, fentanyl and cisatracurium. Group II anesthesia initiated by ketamine, lidocaine, propofol and cisatracurium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: Propofol, Drug: Fentanyl, Drug: CisatracuriumAdministered propofol and fentanyl for induction. |
| Ketamine and lidocaine | Active comparator | Drug: Ketamine, Drug: Propofol, Drug: Cisatracurium, Drug: LidocaineAdministered propofol, ketamine and lidocaine for induction. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I and II between
- Age between 18-55 years
- Undergoing minor surgical procedure less than an hour.
Key exclusion criteria (3 listed)
- Patients with hypertension
- Patients with Ischemic heart diseases
- Patients with chronic renal or liver diseases
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 |
|---|---|---|
| Ketamineketamine | Drug | Ketamine and lidocaine |
| Propofolpropofol | Drug | Fentanyl, Ketamine and lidocaine |
| Fentanylfentanyl | Drug | Fentanyl |
| Cisatracuriumcisatracurium | Drug | Fentanyl, Ketamine and lidocaine |
| Lidocainelidocaine | Drug | Ketamine and lidocaine |
Primary outcome
Intubation with less hemodynamic changes
Time frame: 15 minutes after induction of anesthesia.
changes in blood pressure with intubation
Smooth Maintenance of anesthesia
Time frame: anesthesia time
changes in blood pressure during anesthesia
less postoperative pain killers
Time frame: 24 hours postoperative
amount of pain killers used and timing
Intubation with less hemodynamic changes
Time frame: Anesthesia time
changes in pulse rate during anesthesia
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 16 Jan 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, Propofol and Fentanyl in people with Anesthesia, run by Ain Shams 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 3 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: finished, as of the sponsor's last update on 16 Jan 2019. 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.
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?
Intubation with less hemodynamic changes (time frame: 15 minutes after induction of anesthesia.). The study lists 4 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 Jan 2019.