Conscious SedationPhase 2NCT03735368
Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery
A Phase 2 study testing Dexmedetomidine Injection, Pregabalin Oral Capsule and topical anesthesia in people with Conscious Sedation, run by Abd-Elazeem Abd-Elhameed Elbakry at 1 site in Egypt.
Trial summary
Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Dexmedetomidine Injection, Pregabalin Oral Capsule and topical anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2018to 29 Nov 2019
- Phase
- Phase 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society Of Anesthesiologists (ASA) I and II physical status.
- Scheduled for cataract extraction under topical anesthesia.
Who cannot join
- Hepatic or renal impairment.
- Taking chronic psychotropic medications.
- Mental instability.
- Morbid obesity.
- Alcohol abuse.
- Substance abuse.
- Pregnant and lactating females.
- History of allergy to the study drugs used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.
Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation.
Read the detailed description
The present study is constructed to evaluate the effect of pregabalin on sedation using dexmedetomidine for cataract surgery under topical anesthesia . In the dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the placebo group (control group) the patients will be premedicated by placebo capsules. All patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic needs and side effects will be assessed as secondary outcome measurements.
- Conditions
- Conscious Sedation
- Being tested
- Dexmedetomidine Injection, Placebo oral capsule, Pregabalin Oral Capsule, topical anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine InjectionDrug
Also called Dexmedetomidine
Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion
Placebo oral capsuleDrug
Also called placebo
placebo oral capsules
Pregabalin Oral CapsuleDrug
Also called pregabalin
150 mg pregabalin Oral Capsule
topical anesthesiaDrug
Also called Benoxinate Hydrochloride 0.4% Eye Drops
topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | placebo oral capsule+ dexmedetomidine+topical anesthesia Receives: Drug: Dexmedetomidine Injection; Drug: Placebo oral capsule; Drug: topical anesthesia |
| Dexmedetomidine- Pregabalin | Active comparator | Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia Receives: Drug: Dexmedetomidine Injection; Drug: Pregabalin Oral Capsule; Drug: topical anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation score changes
Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation.
Measured: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary outcomes (10)
pain score changes
verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor ≥ 3 indicates need of analgesia
Measured: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
heart rate changes
beats/minute
Measured: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
arterial blood pressure changes
mmHg
Measured: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
arterial oxygen saturation
the percentage of hemoglobin saturation with oxygen in arterial blood.
Measured: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
respiratory rate
breath/minute
Measured: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
total dexmedetomidine consumption
ug
Measured: intraoperatively
Incidence of respiratory depression
percentage
Measured: from administering premedication till 24 hours postoperative.
Incidence of hypotension
percentage
Measured: from administering premedication till 24hours postoperative
Incidence of bradycardia
percentage
Measured: from administering premedication till 24hours postoperative
Incidence of ataxia
percentage
Measured: from administering premedication till 24hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start10 Dec 2018
- Primary completion30 Oct 2019
- Study completion29 Nov 2019
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abd-Elazeem Abd-Elhameed Elbakry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University
- Investigators
- Abd-Elazeem A Elbakry, MD, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735368
- Sponsor's protocol ID
- 2018/10/15/5
- Status last verified
- Dec 2019
- First submitted
- 4 Nov 2018
- Last updated
- 27 Dec 2019
- 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 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT03735368
- Acronym / sponsor ID
- 2018/10/15/5
- Conditions
- Conscious Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abd-Elazeem Abd-Elhameed ElbakryUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 8 Nov 2018 (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.
Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation.
Detailed description
The present study is constructed to evaluate the effect of pregabalin on sedation using dexmedetomidine for cataract surgery under topical anesthesia . In the dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the placebo group (control group) the patients will be premedicated by placebo capsules. All patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic needs and side effects will be assessed as secondary outcome measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Dexmedetomidine Injection, Drug: Placebo oral capsule, Drug: topical anesthesiaplacebo oral capsule+ dexmedetomidine+topical anesthesia |
| Dexmedetomidine- Pregabalin | Active comparator | Drug: Dexmedetomidine Injection, Drug: Pregabalin Oral Capsule, Drug: topical anesthesiaPregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society Of Anesthesiologists (ASA) I and II physical status.
- Scheduled for cataract extraction under topical anesthesia.
Key exclusion criteria (8 listed)
- Hepatic or renal impairment.
- Taking chronic psychotropic medications.
- Mental instability.
- Morbid obesity.
- Alcohol abuse.
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 InjectionAlso: DexmedetomidineDexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion | Drug | Control, Dexmedetomidine- Pregabalin |
| Placebo oral capsuleAlso: placeboplacebo oral capsules | Drug | Control |
| Pregabalin Oral CapsuleAlso: pregabalin150 mg pregabalin Oral Capsule | Drug | Dexmedetomidine- Pregabalin |
| topical anesthesiaAlso: Benoxinate Hydrochloride 0.4% Eye Dropstopical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops | Drug | Control, Dexmedetomidine- Pregabalin |
Primary outcome
sedation score changes
Time frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation.
10 secondary outcomes
pain score changes
Time frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
heart rate changes
Time frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
arterial blood pressure changes
Time frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
arterial oxygen saturation
Time frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
respiratory rate
Time frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
total dexmedetomidine consumption
Time frame: intraoperatively
Incidence of respiratory depression
Time frame: from administering premedication till 24 hours postoperative.
Incidence of hypotension
Time frame: from administering premedication till 24hours postoperative
Incidence of bradycardia
Time frame: from administering premedication till 24hours postoperative
Incidence of ataxia
Time frame: from administering premedication till 24hours postoperative
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 27 Dec 2019.
Related trials for Conscious Sedation
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
Active, not recruiting
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Atrial Fibrillation (Paroxysmal)
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Mental Function
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.
Abd-Elazeem A Elbakry, MD principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine Injection, Pregabalin Oral Capsule and topical anesthesia in people with Conscious Sedation, run by Abd-Elazeem Abd-Elhameed Elbakry 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 2 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 27 Dec 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
sedation score changes (time frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours). 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 27 Dec 2019.