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Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

Primary Purpose

Conscious Sedation

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine Injection
Placebo oral capsule
Pregabalin Oral Capsule
topical anesthesia
Sponsored by
Abd-Elazeem Abd-Elhameed Elbakry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conscious Sedation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Dexmedetomidine- Pregabalin

Arm Description

placebo oral capsule+ dexmedetomidine+topical anesthesia

Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia

Outcomes

Primary Outcome Measures

sedation score changes
Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation.

Secondary Outcome Measures

pain score changes
verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor ≥ 3 indicates need of analgesia
heart rate changes
beats/minute
arterial blood pressure changes
mmHg
arterial oxygen saturation
the percentage of hemoglobin saturation with oxygen in arterial blood.
respiratory rate
breath/minute
total dexmedetomidine consumption
ug
Incidence of respiratory depression
percentage
Incidence of hypotension
percentage
Incidence of bradycardia
percentage
Incidence of ataxia
percentage

Full Information

First Posted
November 4, 2018
Last Updated
December 25, 2019
Sponsor
Abd-Elazeem Abd-Elhameed Elbakry
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1. Study Identification

Unique Protocol Identification Number
NCT03735368
Brief Title
Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery
Official Title
Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abd-Elazeem Abd-Elhameed Elbakry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conscious Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The patients, the surgeons and the research team will be blinded to the randomization.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
placebo oral capsule+ dexmedetomidine+topical anesthesia
Arm Title
Dexmedetomidine- Pregabalin
Arm Type
Active Comparator
Arm Description
Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Injection
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
placebo
Intervention Description
placebo oral capsules
Intervention Type
Drug
Intervention Name(s)
Pregabalin Oral Capsule
Other Intervention Name(s)
pregabalin
Intervention Description
150 mg pregabalin Oral Capsule
Intervention Type
Drug
Intervention Name(s)
topical anesthesia
Other Intervention Name(s)
Benoxinate Hydrochloride 0.4% Eye Drops
Intervention Description
topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
Primary Outcome Measure Information:
Title
sedation score changes
Description
Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation.
Time Frame
baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary Outcome Measure Information:
Title
pain score changes
Description
verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor ≥ 3 indicates need of analgesia
Time Frame
baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Title
heart rate changes
Description
beats/minute
Time Frame
baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Title
arterial blood pressure changes
Description
mmHg
Time Frame
baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Title
arterial oxygen saturation
Description
the percentage of hemoglobin saturation with oxygen in arterial blood.
Time Frame
baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Title
respiratory rate
Description
breath/minute
Time Frame
baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Title
total dexmedetomidine consumption
Description
ug
Time Frame
intraoperatively
Title
Incidence of respiratory depression
Description
percentage
Time Frame
from administering premedication till 24 hours postoperative.
Title
Incidence of hypotension
Description
percentage
Time Frame
from administering premedication till 24hours postoperative
Title
Incidence of bradycardia
Description
percentage
Time Frame
from administering premedication till 24hours postoperative
Title
Incidence of ataxia
Description
percentage
Time Frame
from administering premedication till 24hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abd-Elazeem A Elbakry, MD
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Cairo
State/Province
Shebin El-kom
ZIP/Postal Code
32511
Country
Egypt

12. IPD Sharing Statement

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Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

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