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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Conscious Sedation for Cataract Operations Under Topical Anaesthesia

Clinicaltrials.gov identifier NCT03933280

Recruitment Status Active, not recruiting

First Posted May 1, 2019

Last update posted July 7, 2020

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:Conscious Sedation
  • Intervention/Treatment: Drug: Nalbuphine
    Drug: Propofol
    Drug: Dexmedetomidine
    Drug: Benoxinate Hydrochloride 0.4% Eye Drops
  • 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)
  • 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: July 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Active Comparator: Droup D
Nalbuphine/dexmedetomidine group
Drug: Nalbuphine
i.v. nalbuphine bolus of 50 μg/kg.

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.

Drug: Benoxinate Hydrochloride 0.4% Eye Drops
Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.
Active Comparator: Group P
nalbuphine/propofol group
Drug: Nalbuphine
i.v. nalbuphine bolus of 50 μg/kg.

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

Drug: Benoxinate Hydrochloride 0.4% Eye Drops
Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 1. Mean arterial blood pressure [ Time Frame: perioperative ]
    Mean arterial blood pressure in mmHg
  • 2. Heart rate [ Time Frame: perioperative ]
    Heart rate in beats/minutes
  • 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"
Eligibility Criteria
  • Ages Eligible for Study: 20 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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
Contacts
Locations

Egypt, Shebin El-kom
Faculty of Medicine
Cairo

Sponsors and Collaborators

Menoufia University

Investigators

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

More Information
  • Responsible Party: Menoufia University
  • ClinicalTrials.gov Identifier: NCT03933280 History of Changes
  • Other Study ID Numbers: 2019/3/25/9
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: July 7, 2020
  • Last Verified: July 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Cataract