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Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

Sponsor
Abd-Elazeem Abd-Elhameed Elbakry (Other)
Overall Status
Completed
CT.gov ID
NCT03735368
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
11.6
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine Injection
  • Drug: Placebo oral capsule
  • Drug: Pregabalin Oral Capsule
  • Drug: topical anesthesia
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The patients, the surgeons and the research team will be blinded to the randomization.
Primary Purpose:
Treatment
Official Title:
Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.
Actual Study Start Date :
Dec 10, 2018
Actual Primary Completion Date :
Oct 30, 2019
Actual Study Completion Date :
Nov 29, 2019

Arms and Interventions

Arm Intervention/Treatment
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: Pregabalin Oral Capsule
    150 mg pregabalin Oral Capsule
    Other Names:
  • pregabalin

    • Drug: topical anesthesia
    topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
    Other Names:
  • Benoxinate Hydrochloride 0.4% Eye Drops

    		•

    Outcome Measures

    Primary Outcome Measures

    1. sedation score changes [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.

    Secondary Outcome Measures

    1. pain score changes [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

    2. heart rate changes [baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours]

      beats/minute

    3. arterial blood pressure changes [baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours]

      mmHg

    4. arterial oxygen saturation [baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours]

      the percentage of hemoglobin saturation with oxygen in arterial blood.

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

      breath/minute

    6. total dexmedetomidine consumption [intraoperatively]

      ug

    7. Incidence of respiratory depression [from administering premedication till 24 hours postoperative.]

      percentage

    8. Incidence of hypotension [from administering premedication till 24hours postoperative]

      percentage

    9. Incidence of bradycardia [from administering premedication till 24hours postoperative]

      percentage

    10. Incidence of ataxia [from administering premedication till 24hours postoperative]

      percentage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Cairo Shebin El-kom Egypt 32511

    Sponsors and Collaborators

    • Abd-Elazeem Abd-Elhameed Elbakry

    Investigators

    • Principal Investigator: Abd-Elazeem A Elbakry, MD, Assistant professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abd-Elazeem Abd-Elhameed Elbakry, assistant professor, Menoufia University
    ClinicalTrials.gov Identifier:
    NCT03735368
    Other Study ID Numbers:
    • 2018/10/15/5
    First Posted:
    Nov 8, 2018
    Last Update Posted:
    Dec 27, 2019
    Last Verified:
    Dec 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Pregabalin
    Dexmedetomidine
    Benoxinate

    Study Results

    No Results Posted as of Dec 27, 2019