Sedation for Patients Undergoing Peribulbar BlockPhase 1NCT04658732
A Comparative Study of Oral Gabapentin, Oral Alprazolam and Intravenous Dexmedetomidine on Perioperative Anxiety and Pain During Posterior Segment Eye Surgery Under Peribulbar Block : a Randomized, Double-blind Study.
A Phase 1 study testing Administration of Alprazolam , Gabapentin , Dexmedetomidine in people with Sedation for Patients Undergoing Peribulbar Block, run by Ehab Tarek Fahmy at 1 site in Egypt.
Trial summary
We hypothesized that gabapentin when given orally as a premedication in patients who perform posterior segment eye surgery under peribulbar block would provide adequate anxiolysis and arousable sedation as alprazolam and dexmedetomidine with minimal side effects . Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Sedation for Patients Undergoing Peribulbar Block
- What is being tested?
- Administration of Alprazolam , Gabapentin , Dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Aug 2021
- Phase
- Phase 1
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 45 to 65 years old, of both sexes.
- ASA 1-2.
- Undergo posterior eye surgery (vitrectomy and retinal detachment) under peribulbar block.
Who cannot join
- Uncooperative patient.
- Communication difficulty resulting from deafness or language barrier.
- Chronic use of narcotics, barbiturate, psychotropic medications or claustrophobia.
- Body weight less than 40 kg or more than 100 kg.
- Known allergy to local anesthetics or any of the study drugs.
- ASA 3-4.
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- Inability to lie supine for the time of surgery or involuntary movement.
- Patients with baseline heart rate (HR) <60/min, severe left ventricular dysfunction (EF <30%), hypovolaemia with systolic blood pressure (SBP) <90 mmHg, Mobitz type 2 or 3rd degree heart block, severe valvular disease (valve stenosis/regurgitation), asthma, chronic cough, upper respiratory tract infection within the previous 2 weeks, chronic renal failure and hepatic impairment will be excluded from the study.
- Patients on medications can affect the removal of alprazolam from the body, which may affect how alprazolam works. Examples include azole antifungals (such as itraconazole, ketoconazole),cimetidine, certain antidepressants (such as fluoxetine, fluvoxamine, nefazodone ),drugs to treat HIV( delavirdine, protease inhibitors such as indinavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St.John's Wort and drugs used to treat seizures (such as phenytoin).
- Patients with myasthenia gravis or myoclonus problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Ainy School of Medicine
Giza, 11211
ismail ahmed ismail, McS, 01000844089, dr.ismail.Gp2014@gmail.comgmail.com
Ehab Tarek, McS, 01091096423, ehabtarek89@gmail.com
About this study
We hypothesized that gabapentin when given orally as a premedication in patients who perform posterior segment eye surgery under peribulbar block would provide adequate anxiolysis and arousable sedation as alprazolam and dexmedetomidine with minimal side effects .
Read the detailed description
The principle goal of sedation for eye surgery is to prepare the patients to stay calm during surgery. Both insufficient sedation and deep sedation may lead to sudden movements by patients, which may potentially result in harmful complications during eye surgery. Several drugs such as propofol, opioids, and dexmedetomidine have been used for sedation during this procedure [1]. However, each of these drugs has its own limitations, leading to impairment of patient's cooperation during surgery. Therefore, the potential clinical advantages of newly-marketed therapeutic drugs should be thoroughly evaluated. [2] Benzodiazepines are amongst the most popular preoperative medication to produce anxiolysis, amnesia, and sedation for the patients coming for surgery [3]. Benzodiazepines are reported to be paradoxically associated with the increased episodes of arousal during sleep, restlessness, and hangover effects [4]. Alprazolam, a benzodiazepine class of antipsychotic drugs, is more anxioselective than the other premedicants of this group like midazolam, lorazepam, or diazepam [5]. It has also been reported to show arousal episodes and may cause psychomotor impairment which is a disadvantage to be used in elderly in general and in day case in particular [4,6].
Gabapentin is well-tolerated drug that is associated with anxiolytic and antinociceptive properties [2]. It is reported that gabapentin has anxiolytic [7] and antinociceptive effects [8,9]. In another study, it is claimed that this drug does not depress respiration with no effect on gastric mucosa, platelets, and renal function [9]. Moreover, gabapentin seems to be an anxiolytic without amnesic effects which is an important advantage for elderly patients. Leung and colleagues reported that delirium is significantly less in patients receiving gabapentin before spine surgery[10].
Dexmedetomidine, a highly selective α2 agonist, has been widely used as a sedative in a variety of clinical settings owing to its analgesic properties, minimal respiratory depression and easy arousability [11,12].Hypotension and bradycardia, the most frequent side effects of dexmedetomidine [12], occur in a dose-related manner [13,14]. To avoid these side effects, a dose adjustment is required. For procedural sedation, a loading dose of 0.25μg/kg over 10 min followed by maintenance dose of 0.25μg/kg/h provides an adequate level of sedation, stable hemodynamics and better surgeon satisfaction [15].
In this study, we planned to compare the sedative effects of oral gabapentin, alprazolam and intravenous of dexmedetomidine on various parameters including anxiety, sedation and orientation. In our literature review, we could not find any study comparing the effect of gabapentin and alprazolam on anxiety, pain, sedation scores, satisfaction of surgeon, and hemodynamic parameters in posterior segment eye surgery under peribulbar block.
- Being tested
- Administration of Alprazolam , Gabapentin , Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Alprazolam , Gabapentin , DexmedetomidineDrug
Patients will be allocated into one of the 3 groups: Alprazolam (A group), Gabapentin (G group) and Dexmedetomidine (D group) as control group. Alprazolam group (n=15): patients in this group will receive 0.25 mg Alprazolam (2 tablets of Xanax 0.125 mg manufactured by Pfizer). Gabapentin group (n=15): patients in this group will receive 600mg Gabapentin (2 capsules of Neurontin 300 mg manufactured by Pfizer).Control group (n=15): patients in this group will receive 2 tablets of multivitamin (Vitamax manufactured by GlaxoSmithKline S.A.E) as placebo to ensure blindness of the study. The study drug will be received 120 minutes before the operation.
| Study group | Role | What they receive |
|---|---|---|
| Alprazolam (A group) | Experimental | patients in this group will receive 0.25 mg Alprazolam (2 tablets of Xanax 0.125 mg manufactured by Pfizer. Receives: Drug: Administration of Alprazolam , Gabapentin , Dexmedetomidine |
| Gabapentin (G group) | Experimental | patients in this group will receive 600mg Gabapentin (2 capsules of Neurontin 300 mg manufactured by Pfizer. Receives: Drug: Administration of Alprazolam , Gabapentin , Dexmedetomidine |
| Dexmedetomidine (D group) | Experimental | Dexmedetomidine 0.25 µg/kg loading dose will be infused intravenously over 10 minutes through syringe pump before surgery in the control group (Prepared using Precedex vial 200mcg/2ml manufactured by Hospira Inc, Highway 301,Rocky Mount,NC 278001 USA) Receives: Drug: Administration of Alprazolam , Gabapentin , Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
The sedation level of patients using Ramsay sedation scale (RSS) [19] during surgery will be assessed every 5 min for the first 15 min (5, 10, 15), every 15 min until the end of surgery and every 30 min for 2 h in the post-operative ward.
Measured: intraoperative and 2 hours postoperative . along time of the study
Secondary outcomes (1)
Secondary outcome
- The verbal pain score (VPS) ranging from 0 to10 (0 = no pain and 10 = worst pain imaginable) will be fully explained to patients
Measured: intraoperative and 2 hours postoperative . along time of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation for Patients Undergoing Peribulbar BlockStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blinded study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ehab Tarek Fahmy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ehab Tarek Fahmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658732
- Sponsor's protocol ID
- MD-240-2019
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Oral Gabapentin, Oral Alprazolam and Intravenous Dexmedetomidine on Perioperative Anxiety and Pain During Posterior Segment Eye Surgery Under Peribulbar Block : a Randomized, Double-blind Study.
- ClinicalTrials.gov ID
- NCT04658732
- Acronym / sponsor ID
- MD-240-2019
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ehab Tarek FahmyUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 8 Dec 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.
We hypothesized that gabapentin when given orally as a premedication in patients who perform posterior segment eye surgery under peribulbar block would provide adequate anxiolysis and arousable sedation as alprazolam and dexmedetomidine with minimal side effects .
Detailed description
The principle goal of sedation for eye surgery is to prepare the patients to stay calm during surgery. Both insufficient sedation and deep sedation may lead to sudden movements by patients, which may potentially result in harmful complications during eye surgery. Several drugs such as propofol, opioids, and dexmedetomidine have been used for sedation during this procedure [1]. However, each of these drugs has its own limitations, leading to impairment of patient's cooperation during surgery. Therefore, the potential clinical advantages of newly-marketed therapeutic drugs should be thoroughly evaluated. [2] Benzodiazepines are amongst the most popular preoperative medication to produce anxiolysis, amnesia, and sedation for the patients coming for surgery [3]. Benzodiazepines are reported to be paradoxically associated with the increased episodes of arousal during sleep, restlessness, and hangover effects [4]. Alprazolam, a benzodiazepine class of antipsychotic drugs, is more anxioselective than the other premedicants of this group like midazolam, lorazepam, or diazepam [5]. It has also been reported to show arousal episodes and may cause psychomotor impairment which is a disadvantage to be used in elderly in general and in day case in particular [4,6].
Gabapentin is well-tolerated drug that is associated with anxiolytic and antinociceptive properties [2]. It is reported that gabapentin has anxiolytic [7] and antinociceptive effects [8,9]. In another study, it is claimed that this drug does not depress respiration with no effect on gastric mucosa, platelets, and renal function [9]. Moreover, gabapentin seems to be an anxiolytic without amnesic effects which is an important advantage for elderly patients. Leung and colleagues reported that delirium is significantly less in patients receiving gabapentin before spine surgery[10].
Dexmedetomidine, a highly selective α2 agonist, has been widely used as a sedative in a variety of clinical settings owing to its analgesic properties, minimal respiratory depression and easy arousability [11,12].Hypotension and bradycardia, the most frequent side effects of dexmedetomidine [12], occur in a dose-related manner [13,14]. To avoid these side effects, a dose adjustment is required. For procedural sedation, a loading dose of 0.25μg/kg over 10 min followed by maintenance dose of 0.25μg/kg/h provides an adequate level of sedation, stable hemodynamics and better surgeon satisfaction [15].
In this study, we planned to compare the sedative effects of oral gabapentin, alprazolam and intravenous of dexmedetomidine on various parameters including anxiety, sedation and orientation. In our literature review, we could not find any study comparing the effect of gabapentin and alprazolam on anxiety, pain, sedation scores, satisfaction of surgeon, and hemodynamic parameters in posterior segment eye surgery under peribulbar block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Randomized double blinded study.
| Arm | Type | Receives |
|---|---|---|
| Alprazolam (A group) | Experimental | Drug: Administration of Alprazolam , Gabapentin , Dexmedetomidinepatients in this group will receive 0.25 mg Alprazolam (2 tablets of Xanax 0.125 mg manufactured by Pfizer. |
| Gabapentin (G group) | Experimental | Drug: Administration of Alprazolam , Gabapentin , Dexmedetomidinepatients in this group will receive 600mg Gabapentin (2 capsules of Neurontin 300 mg manufactured by Pfizer. |
| Dexmedetomidine (D group) | Experimental | Drug: Administration of Alprazolam , Gabapentin , DexmedetomidineDexmedetomidine 0.25 µg/kg loading dose will be infused intravenously over 10 minutes through syringe pump before surgery in the control group (Prepared using Precedex vial 200mcg/2ml manufactured by Hospira Inc, Highway 301,Rocky Mount,NC 278001 USA) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged from 45 to 65 years old, of both sexes.
- ASA 1-2.
- Undergo posterior eye surgery (vitrectomy and retinal detachment) under peribulbar block.
Key exclusion criteria (10 listed)
- Uncooperative patient.
- Communication difficulty resulting from deafness or language barrier.
- Chronic use of narcotics, barbiturate, psychotropic medications or claustrophobia.
- Body weight less than 40 kg or more than 100 kg.
- Known allergy to local anesthetics or any of the study drugs.
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 |
|---|---|---|
| Administration of Alprazolam , Gabapentin , DexmedetomidinePatients will be allocated into one of the 3 groups: Alprazolam (A group), Gabapentin (G group) and Dexmedetomidine (D group) as control group. Alprazolam group (n=15): patients in this group will receive 0.25 mg Alprazolam (2 tablets of Xanax 0.125 mg manufactured by Pfizer). Gabapentin group (n=15): patients in this group will receive 600mg Gabapentin (2 capsules of Neurontin 300 mg manufactured by Pfizer).Control group (n=15): patients in this group will receive 2 tablets of multivitamin (Vitamax manufactured by GlaxoSmithKline S.A.E) as placebo to ensure blindness of the study. The study drug will be received 120 minutes before the operation. | Drug | Alprazolam (A group), Dexmedetomidine (D group), Gabapentin (G group) |
Primary outcome
primary outcome
Time frame: intraoperative and 2 hours postoperative . along time of the study
The sedation level of patients using Ramsay sedation scale (RSS) [19] during surgery will be assessed every 5 min for the first 15 min (5, 10, 15), every 15 min until the end of surgery and every 30 min for 2 h in the post-operative ward.
1 secondary outcome
Secondary outcome
Time frame: intraoperative and 2 hours postoperative . along time of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: Undecided
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 Phase 1 study testing Administration of Alprazolam , Gabapentin , Dexmedetomidine in people with Sedation for Patients Undergoing Peribulbar Block, run by Ehab Tarek Fahmy 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 10 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 8 Dec 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 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 ismail ahmed ismail, McS (01000844089, dr.ismail.Gp2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome (time frame: intraoperative and 2 hours postoperative . along time of the study). 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 Dec 2020.