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Conscious Sedation for Cataract Operations Under Topical Anaesthesia

Sponsor
Menoufia University (Other)
Overall Status
Completed
CT.gov ID
NCT03933280
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
18.1
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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.
Primary Purpose:
Other
Official Title:
Nalbuphine/Dexmedetomidine Versus Nalbuphine/Propofol Conscious Sedation for Cataract Extraction Under Topical Anaesthesia: A Double-Blind Randomized Trial
Actual Study Start Date :
Jul 1, 2019
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

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: 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

    • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sedation score [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 Outcome Measures

    1. Heart rate [perioperative]

      Heart rate in beats/minutes

    2. Mean arterial blood pressure [perioperative]

      Mean arterial blood pressure in mmHg

    3. Oxygen saturation [perioperative]

      Arterial oxygen saturation as a percentage of the total haemoglobin

    4. Analgesia [perioperative]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Cairo Shebin El-kom Egypt 32511

    Sponsors and Collaborators

    • Menoufia University

    Investigators

    • Principal Investigator: Abd-Elazeem A Elbakry, MD, Associate professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abd-Elazeem Abd-Elhameed Elbakry, Associate professor of anaesthesia, Menoufia University
    ClinicalTrials.gov Identifier:
    NCT03933280
    Other Study ID Numbers:
    • 2019/3/25/9
    First Posted:
    May 1, 2019
    Last Update Posted:
    Jan 8, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Dexmedetomidine
    Nalbuphine
    Propofol
    Benoxinate
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Jan 8, 2021