NCT03933280

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Conscious Sedation

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-12-01
• Completion: 2021-01-01
• First posted: 2019-05-01
• Last updated: 2021-01-08

Locations

1 site across 1 country: Egypt