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Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

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ClinicalTrials.gov Identifier: NCT03735368
Recruitment Status : Active, not recruiting
First Posted : November 8, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University

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
Conscious Sedation 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.

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Study Type : Interventional  (Clinical Trial)
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 : December 10, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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 Name: Dexmedetomidine

Drug: Placebo oral capsule
placebo oral capsules
Other Name: placebo

Drug: topical anesthesia
topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
Other Name: 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 Name: Dexmedetomidine

Drug: Pregabalin Oral Capsule
150 mg pregabalin Oral Capsule
Other Name: pregabalin

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. heart rate changes [ Time Frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours ]
    beats/minute

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

  4. 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.

  5. respiratory rate [ Time Frame: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours ]
    breath/minute

  6. total dexmedetomidine consumption [ Time Frame: intraoperatively ]
    ug

  7. Incidence of respiratory depression [ Time Frame: from administering premedication till 24 hours postoperative. ]
    percentage

  8. Incidence of hypotension [ Time Frame: from administering premedication till 24hours postoperative ]
    percentage

  9. Incidence of bradycardia [ Time Frame: from administering premedication till 24hours postoperative ]
    percentage

  10. Incidence of ataxia [ Time Frame: from administering premedication till 24hours postoperative ]
    percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735368


Locations
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Egypt
Faculty of Medicine
Cairo, Shebin El-kom, Egypt, 32511
Sponsors and Collaborators
Abd-Elazeem Abd-Elhameed Elbakry
Investigators
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Principal Investigator: Abd-Elazeem A Elbakry, MD Assistant professor

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Responsible Party: Abd-Elazeem Abd-Elhameed Elbakry, assistant professor, Menoufia University
ClinicalTrials.gov Identifier: NCT03735368     History of Changes
Other Study ID Numbers: 2018/10/15/5
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Pregabalin
Dexmedetomidine
Anesthetics
Benoxinate
Procaine
Ophthalmic Solutions
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Pharmaceutical Solutions