Conscious Sedation for Cataract Operations Under Topical Anaesthesia

NCT ID: NCT03933280

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-01-01

Brief 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

Detailed 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.

Conditions

Conscious Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group P

nalbuphine/propofol group

Group Type: ACTIVE_COMPARATOR

Nalbuphine

Intervention Type: DRUG

i.v. nalbuphine bolus of 50 μg/kg.

Propofol

Intervention Type: DRUG

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

Benoxinate Hydrochloride 0.4% Eye Drops

Intervention Type: DRUG

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

Droup D

Nalbuphine/dexmedetomidine group

Group Type: ACTIVE_COMPARATOR

Nalbuphine

Intervention Type: DRUG

i.v. nalbuphine bolus of 50 μg/kg.

Dexmedetomidine

Intervention Type: DRUG

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

Benoxinate Hydrochloride 0.4% Eye Drops

Intervention Type: DRUG

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

Interventions

Nalbuphine

i.v. nalbuphine bolus of 50 μg/kg.

Intervention Type: DRUG

Propofol

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

Intervention Type: 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.

Intervention Type: DRUG

Benoxinate Hydrochloride 0.4% Eye Drops

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

Intervention Type: DRUG

Other Intervention Names

Nalbuphine bolus; propofol infusion; Dexmedetomidine infusion; Topical anaesthesia of the eye

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Abd-Elazeem Abd-Elhameed Elbakry

Associate professor of anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abd-Elazeem A Elbakry, MD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

Faculty of Medicine

Cairo, Shebin El-kom, Egypt

Countries

Egypt

Other Identifiers

2019/3/25/9

Identifier Type: -

Identifier Source: org_study_id