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.

December 5, 2020 updated by: Ehab Tarek Fahmy
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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:• Patient refusal.

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alprazolam (A group)
patients in this group will receive 0.25 mg Alprazolam (2 tablets of Xanax 0.125 mg manufactured by Pfizer.
Drug: Administration of Alprazolam , Gabapentin , Dexmedetomidine
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.
Experimental: Gabapentin (G group)
patients in this group will receive 600mg Gabapentin (2 capsules of Neurontin 300 mg manufactured by Pfizer.
Drug: Administration of Alprazolam , Gabapentin , Dexmedetomidine
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.
Experimental: Dexmedetomidine (D group)
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)
Drug: Administration of Alprazolam , Gabapentin , Dexmedetomidine
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
intraoperative and 2 hours postoperative . along time of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary outcome
Time Frame: intraoperative and 2 hours postoperative . along time of the study
• The verbal pain score (VPS) ranging from 0 to10 (0 = no pain and 10 = worst pain imaginable) will be fully explained to patients
intraoperative and 2 hours postoperative . along time of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ehab Tarek Fahmy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MD-240-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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