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出境医 / 临床实验 / Conscious Sedation for Cataract Operations Under Topical Anaesthesia
Conscious Sedation for Cataract Operations Under Topical Anaesthesia
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 | Intervention/treatment | Phase |
|---|---|---|
| Conscious Sedation | Drug: Nalbuphine Drug: Propofol Drug: Dexmedetomidine Drug: Benoxinate Hydrochloride 0.4% Eye Drops | 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 (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | An independent anaesthesiologist not involved in the study will open the randomisation envelope just before the premedication and will prepare the appropriate drug-filled syringes according to the code and will not take part in the management and observations. (Syringes and infusion lines will be concealed by wrapping with an aluminium foil). A blinded investigator that will not be involved in the anaesthetic management of the patients, will collect the intra-operative and postoperative data. |
| 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 1, 2019 |
| Actual Primary Completion Date : | December 1, 2020 |
| Actual Study Completion Date : | January 1, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Group P
nalbuphine/propofol group
|
Drug: Nalbuphine
i.v. nalbuphine bolus of 50 μg/kg.
Other Name: Nalbuphine bolus
Drug: Propofol A bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min
Other Name: propofol infusion
Drug: Benoxinate Hydrochloride 0.4% Eye Drops Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.
Other Name: Topical anaesthesia of the eye
|
|
Active Comparator: Droup D
Nalbuphine/dexmedetomidine group
|
Drug: Nalbuphine
i.v. nalbuphine bolus of 50 μg/kg.
Other Name: Nalbuphine bolus
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.
Other Name: Dexmedetomidine infusion
Drug: Benoxinate Hydrochloride 0.4% Eye Drops Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.
Other Name: Topical anaesthesia of the eye
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- Heart rate [ Time Frame: perioperative ]Heart rate in beats/minutes
- Mean arterial blood pressure [ Time Frame: perioperative ]Mean arterial blood pressure in mmHg
- Oxygen saturation [ Time Frame: perioperative ]Arterial oxygen saturation as a percentage of the total haemoglobin
- 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 Years 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
Locations
| Egypt | |
| Faculty of Medicine | |
| Cairo, Shebin El-kom, Egypt, 32511 | |
Sponsors and Collaborators
Menoufia University
Investigators
| Principal Investigator: | Abd-Elazeem A Elbakry, MD | Associate professor |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 26, 2019 | ||||
| First Posted Date ICMJE | May 1, 2019 | ||||
| Last Update Posted Date | January 8, 2021 | ||||
| Actual Study Start Date ICMJE | July 1, 2019 | ||||
| Actual Primary Completion Date | December 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE |
Sedation score [ Time Frame: perioperative ] Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Conscious Sedation for Cataract Operations Under Topical Anaesthesia | ||||
| Official Title ICMJE | Nalbuphine/Dexmedetomidine Versus Nalbuphine/Propofol Conscious Sedation for Cataract Extraction Under Topical Anaesthesia: A Double-Blind Randomized Trial | ||||
| 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Masking Description: An independent anaesthesiologist not involved in the study will open the randomisation envelope just before the premedication and will prepare the appropriate drug-filled syringes according to the code and will not take part in the management and observations. (Syringes and infusion lines will be concealed by wrapping with an aluminium foil). A blinded investigator that will not be involved in the anaesthetic management of the patients, will collect the intra-operative and postoperative data. Primary Purpose: Other
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| Condition ICMJE | Conscious Sedation | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | January 1, 2021 | ||||
| Actual Primary Completion Date | December 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 20 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03933280 | ||||
| Other Study ID Numbers ICMJE | 2019/3/25/9 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University | ||||
| Study Sponsor ICMJE | Menoufia University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Menoufia University | ||||
| Verification Date | January 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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