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Conscious Sedation for Cataract Operations Under Topical Anaesthesia

NCT03933280 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-08

No results posted yet for this study

Summary

Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. Sedation during topical anaesthesia of the eye is mostly required to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. In the present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative, postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as secondary outcomes

Conditions

  • Conscious Sedation

Interventions

DRUG

Nalbuphine

i.v. nalbuphine bolus of 50 μg/kg.

DRUG

Propofol

A bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min

DRUG

Dexmedetomidine

i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h.

DRUG

Benoxinate Hydrochloride 0.4% Eye Drops

Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.

Sponsors & Collaborators

  • Menoufia University

    lead OTHER

Principal Investigators

  • Abd-Elazeem A Elbakry, MD · Associate professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-12-01
Completion
2021-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933280 on ClinicalTrials.gov