Conscious SedationPhase 1/2NCT04621526
Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol For Chronic Subdural Hematoma
A Phase 1/2 study testing dexmedetomidine- ketamine and dexmedetomidine- propofol in people with Conscious Sedation, run by Zagazig University at 1 site in Egypt.
Trial summary
Inadequate sedation and analgesia indicated by intraoperative movements are markers of inadequate MAC during burr-hole surgery for chronic subdural hematoma evacuation especially when general anesthesia poses high risk for the patients. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- dexmedetomidine- ketamine and dexmedetomidine- propofol
- 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
- 10 Nov 2020to 30 Aug 2023
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient acceptance.
- Both sex.
- Age (50-80) years old.
- Patient with Body Mass Index (BMI) (25-30kg/m²).
- American Society of Anesthesiologist (ASA) II / III
- patient scheduled to burr-hole surgery for chronic subdural hematoma evacuation under MAC.
Who cannot join
- Patient with difficult airway (mallapati III,IV).
- Altered mental status (psychiatric and anexity disorder).
- Post-traumatic stress disorders.
- History of allergy to study drugs.
- Patient on sedative or hypnotic medication.
- Patients with on painkiller.
- Patients with any degree of heart block.
- Sever liver, respiratory or renal impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol Combination During Burr-Hole Surgery For Chronic Subdural Hematoma
Inadequate sedation and analgesia indicated by intraoperative movements are markers of inadequate MAC during burr-hole surgery for chronic subdural hematoma evacuation especially when general anesthesia poses high risk for the patients.
Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to provide monitored anesthesia care with variable success if used as solitary agents as each drug has its limited use.
Read the detailed description
- Null hypothesis (H0): There are no differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
- Alternative hypothesis (H1): There are differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
- Conditions
- Conscious Sedation
- Being tested
- dexmedetomidine- ketamine, dexmedetomidine- propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine- ketamineDrug
Also called precedex- katalar
patients will receive combination of ketamine 1mg/kg and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
dexmedetomidine- propofolDrug
Also called precedex- diprivan
patients will receive combination from 0.5 mg/kg propofol and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine- ketamine | Active comparator | patients will receive combination of ketamine 1mg/kg and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture. Receives: Drug: dexmedetomidine- ketamine |
| dexmedetomidine- propofol | Active comparator | patients will receive combination from 1 mg/kg propofol and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 1 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture. Receives: Drug: dexmedetomidine- propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The onset time of sedation
The onset of sedation will be recorded. It is defined as the time from injection of sedative medications till reaching a target sedation level score 3 by modified Observer's Assessment of Alertness and sedation score (OAA/S).
Measured: with in 30 minutes before start of surgery
Secondary outcomes (6)
The extent of airway obstruction
The extent of airway obstruction by (1= patent airway, 2= airway obstruction alleviated by jaw thrust, 3= airway obstruction alleviated by positive mask ventilation)
Measured: intraopertive
rescue analgesic (fentanyl)
Total number of calling intraoperative rescue analgesic (fentanyl) in both groups will be recorded.
Measured: intraoperative
number of participant with complications
Intraoperative complications such as hypotension (mean arterial blood pressure decreases by > 20% of basal reading), bradycardia (HR decreases by > 20% of basal reading) and bradypnea (RR less than 10 b/m) or hypoxemia (SpO2 less than 95%
Measured: intraoperative
Recovery time
Recovery time: time from discontinuation of infusion drugs till spontaneous eye opening.
Measured: with in one hour postoperative
The Neurological status of participants
The Neurological status of participants will be assessed before discharge in the PACU using Markwalder's Neurological Grading scale (MNGs) and recorded:
Grade 0: no neurologic deficit Grade I: mild symptoms such as headache; absent or mild neurologic deficits such as reflex asymmetry Grade II: drowsiness or disorientation with variable neurologic deficits such as hemiparesis Grade III: stupor, but appropriate responses to noxious stimuli; severe focal signs such as hemiplegia Grade IV: coma with absence of motor response to painful stimuli; decerebrate or decorticate posturing.
Measured: at baseline then within one hour postoperative
surgeon satisfaction
surgeon satisfaction using 7- point Likert-like verbal rating scale by asking about how they evaluate their experience with anesthetic management during surgery?" score will be 6 and 7 if they are satisfied.5=very satisfied, 4=satisfied, 3= neutral, 2= unsatisfied and 1= very unsatisfied.
Measured: with in 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start10 Nov 2020
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious 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 (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa Kamel, M.D, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621526
- Sponsor's protocol ID
- 6434
- Status last verified
- Oct 2023
- First submitted
- 28 Oct 2020
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol Combination During Burr-Hole Surgery For Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT04621526
- Acronym / sponsor ID
- 6434
- Conditions
- Conscious Sedation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 9 Nov 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.
Inadequate sedation and analgesia indicated by intraoperative movements are markers of inadequate MAC during burr-hole surgery for chronic subdural hematoma evacuation especially when general anesthesia poses high risk for the patients.
Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to provide monitored anesthesia care with variable success if used as solitary agents as each drug has its limited use.
Detailed description
- Null hypothesis (H0): There are no differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
- Alternative hypothesis (H1): There are differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine- ketamine | Active comparator | Drug: dexmedetomidine- ketaminepatients will receive combination of ketamine 1mg/kg and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture. |
| dexmedetomidine- propofol | Active comparator | Drug: dexmedetomidine- propofolpatients will receive combination from 1 mg/kg propofol and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 1 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient acceptance.
- Both sex.
- Age (50-80) years old.
- Patient with Body Mass Index (BMI) (25-30kg/m²).
- American Society of Anesthesiologist (ASA) II / III
Key exclusion criteria (8 listed)
- Patient with difficult airway (mallapati III,IV).
- Altered mental status (psychiatric and anexity disorder).
- Post-traumatic stress disorders.
- History of allergy to study drugs.
- Patient on sedative or hypnotic medication.
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 |
|---|---|---|
| dexmedetomidine- ketamineAlso: precedex- katalarpatients will receive combination of ketamine 1mg/kg and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture. | Drug | dexmedetomidine- ketamine |
| dexmedetomidine- propofolAlso: precedex- diprivanpatients will receive combination from 0.5 mg/kg propofol and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture. | Drug | dexmedetomidine- propofol |
Primary outcome
The onset time of sedation
Time frame: with in 30 minutes before start of surgery
The onset of sedation will be recorded. It is defined as the time from injection of sedative medications till reaching a target sedation level score 3 by modified Observer's Assessment of Alertness and sedation score (OAA/S).
6 secondary outcomes
The extent of airway obstruction
Time frame: intraopertive
rescue analgesic (fentanyl)
Time frame: intraoperative
number of participant with complications
Time frame: intraoperative
Recovery time
Time frame: with in one hour postoperative
The Neurological status of participants
Time frame: at baseline then within one hour postoperative
surgeon satisfaction
Time frame: with in 24 hours after surgery
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 17 Oct 2023.
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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.
Alshaimaa Kamel, M.D 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 dexmedetomidine- ketamine and dexmedetomidine- propofol in people with Conscious 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 6 inclusion and 8 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 17 Oct 2023. 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?
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?
The onset time of sedation (time frame: with in 30 minutes before start of surgery). 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 17 Oct 2023.