Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

December 25, 2019 updated by: Abd-Elazeem Abd-Elhameed Elbakry

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.

Study Overview

Status

Status

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

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 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 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 (Actual)

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.
60

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 2

Contacts and Locations

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

Study Locations

  • Egypt
    • Shebin El-kom
      • Cairo, Shebin El-kom, Egypt, 32511
        • Faculty of Medicine

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society Of Anesthesiologists (ASA) I and II physical status.
  • Scheduled for cataract extraction under topical anesthesia.

Exclusion Criteria:

  • 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

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: Quadruple

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.
Placebo Comparator: Control
placebo oral capsule+ dexmedetomidine+topical anesthesia
Drug: Dexmedetomidine Injection
Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion
Other Names:
  • Dexmedetomidine
Drug: Placebo oral capsule
placebo oral capsules
Other Names:
  • placebo
Drug: topical anesthesia
topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
Other Names:
  • Benoxinate Hydrochloride 0.4% Eye Drops
Active Comparator: Dexmedetomidine- Pregabalin
Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia
Drug: Dexmedetomidine Injection
Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion
Other Names:
  • Dexmedetomidine
Drug: topical anesthesia
topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
Other Names:
  • Benoxinate Hydrochloride 0.4% Eye Drops
Drug: Pregabalin Oral Capsule
150 mg pregabalin Oral Capsule
Other Names:
  • pregabalin

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
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.
baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours

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
pain score changes
Time Frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor ≥ 3 indicates need of analgesia
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
beats/minute
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
mmHg
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
the percentage of hemoglobin saturation with oxygen in arterial blood.
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
breath/minute
baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
total dexmedetomidine consumption
Time Frame: intraoperatively
ug
intraoperatively
Incidence of respiratory depression
Time Frame: from administering premedication till 24 hours postoperative.
percentage
from administering premedication till 24 hours postoperative.
Incidence of hypotension
Time Frame: from administering premedication till 24hours postoperative
percentage
from administering premedication till 24hours postoperative
Incidence of bradycardia
Time Frame: from administering premedication till 24hours postoperative
percentage
from administering premedication till 24hours postoperative
Incidence of ataxia
Time Frame: from administering premedication till 24hours postoperative
percentage
from administering premedication till 24hours postoperative

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.
Abd-Elazeem Abd-Elhameed Elbakry

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abd-Elazeem A Elbakry, MD, Assistant Professor

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 10, 2018

Primary Completion (Actual)

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.
October 30, 2019

Study Completion (Actual)

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.
November 29, 2019

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).
November 4, 2018

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.
November 6, 2018

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.
November 8, 2018

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 27, 2019

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 25, 2019

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, 2019

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.
  • 2018/10/15/5

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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