Conscious Sedation for Cataract Operations Under Topical Anaesthesia

Conscious Sedation Clinical Trial

Official title:

Nalbuphine/Dexmedetomidine Versus Nalbuphine/Propofol Conscious Sedation for Cataract Extraction Under Topical Anaesthesia: A Double-Blind Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933280
• Other study ID #: 2019/3/25/9
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2021
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Conscious Sedation

Intervention

Drug:
• Nalbuphine
i.v. nalbuphine bolus of 50 µg/kg.
• Propofol
A bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min
• Dexmedetomidine
i.v. loading dose of dexmedetomidine 1 µg/kg over 10 min followed by a maintenance infusion of 0.5 µg/kg/h.
• Benoxinate Hydrochloride 0.4% Eye Drops
Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo	Shebin El-kom

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation score	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.	perioperative
Secondary	Heart rate	Heart rate in beats/minutes	perioperative
Secondary	Mean arterial blood pressure	Mean arterial blood pressure in mmHg	perioperative
Secondary	Oxygen saturation	Arterial oxygen saturation as a percentage of the total haemoglobin	perioperative
Secondary	Analgesia	Measured by Numerical Pain Rating scale where the patient verbally rates pain from 0 "no pain" to 10 "worst imaginable pain"	perioperative