Conscious Sedation for Cataract Operations Under Topical Anaesthesia
- Conditions
- Conscious Sedation
- Interventions
- Registration Number
- NCT03933280
- Lead Sponsor
- Menoufia University
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Both genders,
- 20 and 65 years,
- American Society of Anesthesiologists (ASA) physical status I and II,
- Scheduled for cataract extraction surgery under topical anaesthesia.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Droup D Benoxinate Hydrochloride 0.4% Eye Drops Nalbuphine/dexmedetomidine group Group P Benoxinate Hydrochloride 0.4% Eye Drops nalbuphine/propofol group Group P Nalbuphine nalbuphine/propofol group Group P Propofol nalbuphine/propofol group Droup D Nalbuphine Nalbuphine/dexmedetomidine group Droup D Dexmedetomidine Nalbuphine/dexmedetomidine group
- Primary Outcome Measures
Name Time Method 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
Name Time Method Heart rate perioperative Heart rate in beats/minutes
Oxygen saturation perioperative Arterial oxygen saturation as a percentage of the total haemoglobin
Analgesia perioperative Measured by Numerical Pain Rating scale where the patient verbally rates pain from 0 "no pain" to 10 "worst imaginable pain"
Mean arterial blood pressure perioperative Mean arterial blood pressure in mmHg
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Cairo, Shebin El-kom, Egypt