Conscious Sedation for Cataract Operations Under Topical Anaesthesia

Nalbuphine/Dexmedetomidine Versus Nalbuphine/Propofol Conscious Sedation for Cataract Extraction Under Topical Anaesthesia: A Double-Blind Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Conscious Sedation
• Intervention / Treatment: Drug: Nalbuphine; Drug: Propofol; Drug: Benoxinate Hydrochloride 0.4% Eye Drops; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• 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 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group P; nalbuphine/propofol group	Drug: Nalbuphine; i.v. nalbuphine bolus of 50 μg/kg.; Other Names: Nalbuphine bolus; Drug: Propofol; A bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min; Other Names: propofol infusion; Drug: Benoxinate Hydrochloride 0.4% Eye Drops; Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.; Other Names: Topical anaesthesia of the eye
Active Comparator: Droup D; Nalbuphine/dexmedetomidine group	Drug: Nalbuphine; i.v. nalbuphine bolus of 50 μg/kg.; Other Names: Nalbuphine bolus; Drug: Benoxinate Hydrochloride 0.4% Eye Drops; Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.; Other Names: Topical anaesthesia of the eye; 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.; Other Names: Dexmedetomidine infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate in beats/minutes	perioperative
Mean arterial blood pressure	Mean arterial blood pressure in mmHg	perioperative
Oxygen saturation	Arterial oxygen saturation as a percentage of the total haemoglobin	perioperative
Analgesia	Measured by Numerical Pain Rating scale where the patient verbally rates pain from 0 "no pain" to 10 "worst imaginable pain"	perioperative

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Abd-Elazeem A Elbakry, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

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, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics, Local; Pharmaceutical Solutions; Propofol; Dexmedetomidine; Ophthalmic Solutions; Nalbuphine; Benoxinate
• Other Study ID Numbers: 2019/3/25/9

Drug and device information, study documents

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