Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Conscious Sedation
• Intervention / Treatment: Drug: Dexmedetomidine Injection; Drug: Placebo oral capsule; Drug: topical anesthesia; Drug: Pregabalin Oral Capsule

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Shebin El-kom
    • Cairo, Shebin El-kom, Egypt, 32511
      • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: topical anesthesia; topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops; Other Names: Benoxinate Hydrochloride 0.4% Eye Drops; Drug: Pregabalin Oral Capsule; 150 mg pregabalin Oral Capsule; Other Names: pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score changes	verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor ≥ 3 indicates need of analgesia	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
heart rate changes	beats/minute	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
arterial blood pressure changes	mmHg	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
arterial oxygen saturation	the percentage of hemoglobin saturation with oxygen in arterial blood.	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
respiratory rate	breath/minute	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
total dexmedetomidine consumption	ug	intraoperatively
Incidence of respiratory depression	percentage	from administering premedication till 24 hours postoperative.
Incidence of hypotension	percentage	from administering premedication till 24hours postoperative
Incidence of bradycardia	percentage	from administering premedication till 24hours postoperative
Incidence of ataxia	percentage	from administering premedication till 24hours postoperative

Collaborators and Investigators

• Sponsor: Abd-Elazeem Abd-Elhameed Elbakry
• Investigators: Principal Investigator: Abd-Elazeem A Elbakry, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): November 29, 2019

Study Registration Dates

• First Submitted: November 4, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 25, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Dexmedetomidine; Pregabalin; Benoxinate
• Other Study ID Numbers: 2018/10/15/5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No