NCT03735368

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

November 4, 2018

Last Update Submit

December 25, 2019

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (1)

  • sedation score changes

    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 Outcomes (10)

  • pain score changes

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

  • heart rate changes

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

  • arterial blood pressure changes

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

  • arterial oxygen saturation

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

  • respiratory rate

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

  • +5 more secondary outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

placebo oral capsule+ dexmedetomidine+topical anesthesia

Drug: Dexmedetomidine InjectionDrug: Placebo oral capsuleDrug: topical anesthesia

Dexmedetomidine- Pregabalin

ACTIVE COMPARATOR

Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia

Drug: Dexmedetomidine InjectionDrug: Pregabalin Oral CapsuleDrug: topical anesthesia

Interventions

Dexmedetomidine InjectionDRUG

Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion

Also known as: Dexmedetomidine
ControlDexmedetomidine- Pregabalin
Placebo oral capsuleDRUG

placebo oral capsules

Also known as: placebo
Control
Pregabalin Oral CapsuleDRUG

150 mg pregabalin Oral Capsule

Also known as: pregabalin
Dexmedetomidine- Pregabalin
topical anesthesiaDRUG

topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops

Also known as: Benoxinate Hydrochloride 0.4% Eye Drops
ControlDexmedetomidine- Pregabalin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

Location

MeSH Terms

Interventions

DexmedetomidinePregabalinAnesthesiabenoxinateOphthalmic Solutions

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compoundsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsAnesthesia and AnalgesiaPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Abd-Elazeem A Elbakry, MD

    Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patients, the surgeons and the research team will be blinded to the randomization.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 8, 2018

Study Start

December 10, 2018

Primary Completion

October 30, 2019

Study Completion

November 29, 2019

Last Updated

December 27, 2019

Record last verified: 2019-12

Locations

EG(1)