Conscious Sedation for Cataract Operations Under Topical Anaesthesia

NCT03933280 | Completed Phase 2

• 1 other identifier: 2019/3/25/9
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (1)

• Sedation score

  The degree of sedation assessed by Ramsay sedation score(1 = anxious, agitated, restless;2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response), score of (1) means inadequate sedation. Score (2 to 4) indicates acceptable sedation. Score (5) or (6) excessive sedation.

  perioperative

Secondary Outcomes (4)

• Heart rate

  perioperative

• Mean arterial blood pressure

  perioperative

• Oxygen saturation

  perioperative

• Analgesia

  perioperative

Study Arms (2)

Group P

ACTIVE COMPARATOR

nalbuphine/propofol group

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

Droup D

ACTIVE COMPARATOR

Nalbuphine/dexmedetomidine group

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

Interventions

Nalbuphine DRUG

i.v. nalbuphine bolus of 50 μg/kg.

Also known as: Nalbuphine bolus

Droup D; Group P

Propofol DRUG

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

Also known as: propofol infusion

Group P

Dexmedetomidine DRUG

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

Also known as: Dexmedetomidine infusion

Droup D

Benoxinate Hydrochloride 0.4% Eye Drops DRUG

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

Also known as: Topical anaesthesia of the eye

Droup D; Group P

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

Location

MeSH Terms

Interventions

Nalbuphine; Propofol; Dexmedetomidine; benoxinate; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Abd-Elazeem A Elbakry, MD

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An independent anaesthesiologist not involved in the study will open the randomisation envelope just before the premedication and will prepare the appropriate drug-filled syringes according to the code and will not take part in the management and observations. (Syringes and infusion lines will be concealed by wrapping with an aluminium foil). A blinded investigator that will not be involved in the anaesthetic management of the patients, will collect the intra-operative and postoperative data.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anaesthesia

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 1, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

EG (1)