Conscious SedationPhase 2NCT03933280
Conscious Sedation for Cataract Operations Under Topical Anaesthesia
A Phase 2 study testing Nalbuphine, Propofol and Dexmedetomidine in people with Conscious Sedation, run by Menoufia University at 1 site in Egypt.
Trial summary
Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Nalbuphine, Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Jan 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders,
- 20 and 65 years,
- American Society of Anesthesiologists (ASA) physical status I and II,
- Scheduled for cataract extraction surgery under topical anaesthesia.
Who cannot join
- Known allergy to local anaesthetics,
- Allergy to study drugs,
- Second or third-degree heart block,
- Alcohol or drug abuse
- Morbid obesity, pregnant and lactating females,
- Patients with severe cardiac, renal and hepatic disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nalbuphine/Dexmedetomidine Versus Nalbuphine/Propofol Conscious Sedation for Cataract Extraction Under Topical Anaesthesia: A Double-Blind Randomized Trial
Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. Sedation during topical anaesthesia of the eye is mostly required to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. In the present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative, postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as secondary outcomes
Read the detailed description
In both groups, the patients will receive i.v. nalbuphine 50 μg/kg. Patients in group D, will receive an i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h. Patients in group P, will receive a bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion started at 0.025 mg/kg/min .If sedation score was <3, rescue sedation with boluses of midazolam 0.01 mg/kg will be given. If the patient complained of pain (Numerical verbal pain rating scale ≥3) during the surgery, i.v. fentanyl 50 μg will be given as an intra-operative rescue analgesic and the surgeon will be instructed to use additional topical local anaesthetic eye drops if appropriate. After the completion of surgery, all infusions will be stopped, and the patients will be shifted to the postanaesthetic care unit (PACU) to be monitored for 2 hours before discharge.
- Conditions
- Conscious Sedation
- Being tested
- Nalbuphine, Propofol, Dexmedetomidine, Benoxinate Hydrochloride 0.4% Eye Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Also called Nalbuphine bolus
i.v. nalbuphine bolus of 50 μg/kg.
PropofolDrug
Also called propofol infusion
A bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min
DexmedetomidineDrug
Also called Dexmedetomidine infusion
i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h.
Benoxinate Hydrochloride 0.4% Eye DropsDrug
Also called Topical anaesthesia of the eye
Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | nalbuphine/propofol group Receives: Drug: Nalbuphine; Drug: Propofol; Drug: Benoxinate Hydrochloride 0.4% Eye Drops |
| Droup D | Active comparator | Nalbuphine/dexmedetomidine group Receives: Drug: Nalbuphine; Drug: Dexmedetomidine; Drug: Benoxinate Hydrochloride 0.4% Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation score
The degree of sedation assessed by Ramsay sedation score(1 = anxious, agitated, restless;2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response), score of (1) means inadequate sedation. Score (2 to 4) indicates acceptable sedation. Score (5) or (6) excessive sedation.
Measured: perioperative
Secondary outcomes (4)
Heart rate
Heart rate in beats/minutes
Measured: perioperative
Mean arterial blood pressure
Mean arterial blood pressure in mmHg
Measured: perioperative
Oxygen saturation
Arterial oxygen saturation as a percentage of the total haemoglobin
Measured: perioperative
Analgesia
Measured by Numerical Pain Rating scale where the patient verbally rates pain from 0 "no pain" to 10 "worst imaginable pain"
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Jul 2019
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
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 Menoufia 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University
- Investigators
- Abd-Elazeem A Elbakry, MD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933280
- Sponsor's protocol ID
- 2019/3/25/9
- Status last verified
- Jan 2021
- First submitted
- 26 Apr 2019
- Last updated
- 8 Jan 2021
- 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 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nalbuphine/Dexmedetomidine Versus Nalbuphine/Propofol Conscious Sedation for Cataract Extraction Under Topical Anaesthesia: A Double-Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT03933280
- Acronym / sponsor ID
- 2019/3/25/9
- Conditions
- Conscious Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 1 May 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.
Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. Sedation during topical anaesthesia of the eye is mostly required to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. In the present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative, postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as secondary outcomes
Detailed description
In both groups, the patients will receive i.v. nalbuphine 50 μg/kg. Patients in group D, will receive an i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h. Patients in group P, will receive a bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion started at 0.025 mg/kg/min .If sedation score was <3, rescue sedation with boluses of midazolam 0.01 mg/kg will be given. If the patient complained of pain (Numerical verbal pain rating scale ≥3) during the surgery, i.v. fentanyl 50 μg will be given as an intra-operative rescue analgesic and the surgeon will be instructed to use additional topical local anaesthetic eye drops if appropriate. After the completion of surgery, all infusions will be stopped, and the patients will be shifted to the postanaesthetic care unit (PACU) to be monitored for 2 hours before discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Drug: Nalbuphine, Drug: Propofol, Drug: Benoxinate Hydrochloride 0.4% Eye Dropsnalbuphine/propofol group |
| Droup D | Active comparator | Drug: Nalbuphine, Drug: Dexmedetomidine, Drug: Benoxinate Hydrochloride 0.4% Eye DropsNalbuphine/dexmedetomidine group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders,
- 20 and 65 years,
- American Society of Anesthesiologists (ASA) physical status I and II,
- Scheduled for cataract extraction surgery under topical anaesthesia.
Key exclusion criteria (6 listed)
- Known allergy to local anaesthetics,
- Allergy to study drugs,
- Second or third-degree heart block,
- Alcohol or drug abuse
- Morbid obesity, pregnant and lactating females,
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 |
|---|---|---|
| NalbuphineAlso: Nalbuphine bolusi.v. nalbuphine bolus of 50 μg/kg. | Drug | Droup D, Group P |
| PropofolAlso: propofol infusionA bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min | Drug | Group P |
| DexmedetomidineAlso: Dexmedetomidine infusioni.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h. | Drug | Droup D |
| Benoxinate Hydrochloride 0.4% Eye DropsAlso: Topical anaesthesia of the eyeBenoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart. | Drug | Droup D, Group P |
Primary outcome
Sedation score
Time frame: perioperative
The degree of sedation assessed by Ramsay sedation score(1 = anxious, agitated, restless;2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response), score of (1) means inadequate sedation. Score (2 to 4) indicates acceptable sedation. Score (5) or (6) excessive sedation.
4 secondary outcomes
Heart rate
Time frame: perioperative
Mean arterial blood pressure
Time frame: perioperative
Oxygen saturation
Time frame: perioperative
Analgesia
Time frame: perioperative
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 8 Jan 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.
Abd-Elazeem A Elbakry, MD principal investigator
Associate 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 Nalbuphine, Propofol and Dexmedetomidine in people with Conscious Sedation, run by Menoufia 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 4 inclusion and 6 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 8 Jan 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 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 (time frame: perioperative). 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 8 Jan 2021.