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Completed

NCT Number: NCT03933280

Conscious Sedation for Cataract Operations Under Topical Anaesthesia

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

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nalbuphine

Drug

i.v. nalbuphine bolus of 50 μg/kg.

Other names: Nalbuphine bolus

Propofol

Drug

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

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.

Other names: Dexmedetomidine infusion

Benoxinate Hydrochloride 0.4% Eye Drops

Drug

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

Other names: Topical anaesthesia of the eye

Primary outcomes

  1. Sedation score

    Time frame: perioperative

    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.

Secondary outcomes

  1. Heart rate

    Time frame: perioperative

    Heart rate in beats/minutes

  2. Mean arterial blood pressure

    Time frame: perioperative

    Mean arterial blood pressure in mmHg

  3. Oxygen saturation

    Time frame: perioperative

    Arterial oxygen saturation as a percentage of the total haemoglobin

  4. Analgesia

    Time frame: perioperative

    Measured by Numerical Pain Rating scale where the patient verbally rates pain from 0 "no pain" to 10 "worst imaginable pain"

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 1, 2019
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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