Conscious Sedation for Cataract Operations Under Topical Anaesthesia

Status Completed

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03933280
Study type	Interventional
Source	Menoufia University
Contact
Status	Completed
Phase	Phase 2
Start date	July 1, 2019
Completion date	January 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02573818` - Sedasys Post Approval Study Users Response to System Alarms	N/A
Recruiting	`NCT01100554` - Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy	N/A
Terminated	`NCT00226785` - Dexmedetomidine for Continuous Sedation	Phase 3
Completed	`NCT02518919` - Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies	N/A
Enrolling by invitation	`NCT04172415` - Current Procedural Sedation Practices in a Canadian Community Emergency Department
Completed	`NCT01020643` - Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia	Phase 4
Completed	`NCT00318955` - Post-Marketing Clinical Study to Assess Efficacy and Safety of Dexmedetomidine in Post-Operative Patients	Phase 4
Completed	`NCT04621526` - Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol For Chronic Subdural Hematoma	Phase 1/Phase 2
Completed	`NCT03085563` - A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department	Phase 4
Completed	`NCT01873612` - Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers	Phase 4
Not yet recruiting	`NCT03466242` - IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures	Early Phase 1
Completed	`NCT02679781` - Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care	N/A
Completed	`NCT03885427` - Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery.	Early Phase 1
Completed	`NCT00452426` - Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy	Phase 3
Completed	`NCT00261599` - An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy	Phase 3
Completed	`NCT00641563` - Effects of Two Different Sedation Regimes on Auditory Evoked Potentials and Electroencephalogram (EEG)	N/A
Active, not recruiting	`NCT01118884` - Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children	Phase 3
Terminated	`NCT00809380` - Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial	N/A
Completed	`NCT03886454` - Incidence and Nature of Respiratory Impairment in Consecutive Patients Undergoing Bronchoscopy Under Conscious Sedation: A Pilot Study
Completed	`NCT03925779` - Conscious Sedation for Outpatient Colonoscopy	Phase 2