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Completed

NCT Number: NCT03735368

Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

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.

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Key information

Conditions

Conscious Sedation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Injection

Drug

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

Other names: Dexmedetomidine

Placebo oral capsule

Drug

placebo oral capsules

Other names: placebo

Pregabalin Oral Capsule

Drug

150 mg pregabalin Oral Capsule

Other names: pregabalin

Topical anesthesia

Drug

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

Other names: Benoxinate Hydrochloride 0.4% Eye Drops

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Abd-Elazeem Abd-Elhameed Elbakry

Other

Registry information

Official study title

Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2018
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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