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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03933280
Enrollment
100
Registered
2019-05-01
Start date
2019-07-01
Completion date
2021-01-01
Last updated
2021-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation

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.

Interventions

DRUGNalbuphine

i.v. nalbuphine bolus of 50 μg/kg.

DRUGPropofol

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

DRUGDexmedetomidine

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

DRUGBenoxinate Hydrochloride 0.4% Eye Drops

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

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sedation scoreperioperativeThe 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.

Secondary

MeasureTime frameDescription
Heart rateperioperativeHeart rate in beats/minutes
Mean arterial blood pressureperioperativeMean arterial blood pressure in mmHg
Oxygen saturationperioperativeArterial oxygen saturation as a percentage of the total haemoglobin
AnalgesiaperioperativeMeasured by Numerical Pain Rating scale where the patient verbally rates pain from 0 no pain to 10 worst imaginable pain

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026