Conscious Sedation for Cataract Operations Under Topical Anaesthesia

M

Menoufia University

Status and phase

Completed
Phase 2

Conditions

Conscious Sedation

Treatments

Drug: Propofol
Drug: Nalbuphine
Drug: Benoxinate Hydrochloride 0.4% Eye Drops
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03933280
2019/3/25/9

Details and patient eligibility

About

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

Full description

In both groups, the patients will receive i.v. nalbuphine 50 μg/kg. Patients in group D, will receive an i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h. Patients in group P, will receive a bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion started at 0.025 mg/kg/min .If sedation score was <3, rescue sedation with boluses of midazolam 0.01 mg/kg will be given. If the patient complained of pain (Numerical verbal pain rating scale ≥3) during the surgery, i.v. fentanyl 50 μg will be given as an intra-operative rescue analgesic and the surgeon will be instructed to use additional topical local anaesthetic eye drops if appropriate. After the completion of surgery, all infusions will be stopped, and the patients will be shifted to the postanaesthetic care unit (PACU) to be monitored for 2 hours before discharge.

Enrollment

100 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Both genders,
  • 20 and 65 years,
  • American Society of Anesthesiologists (ASA) physical status I and II,
  • Scheduled for cataract extraction surgery under topical anaesthesia.

Exclusion criteria

  • Known allergy to local anaesthetics,
  • Allergy to study drugs,
  • Second or third-degree heart block,
  • Alcohol or drug abuse
  • Morbid obesity, pregnant and lactating females,
  • Patients with severe cardiac, renal and hepatic disorders.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Group P
Active Comparator group
Description:
nalbuphine/propofol group
Treatment:
Drug: Benoxinate Hydrochloride 0.4% Eye Drops
Drug: Nalbuphine
Drug: Propofol
Droup D
Active Comparator group
Description:
Nalbuphine/dexmedetomidine group
Treatment:
Drug: Dexmedetomidine
Drug: Benoxinate Hydrochloride 0.4% Eye Drops
Drug: Nalbuphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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