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Dexmedetomidine as an Additive to Local Anaesthesia to Decrease Intraocular Pressure in Glaucoma Surgery

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine to reduce the IOP
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patients who were ASA I-III, age more than 25 and less than 80 with diagnosed increased intraocular pressure and were legible for surgical correction

Exclusion Criteria:

  • Patients with known allergy to the medications to be given, ASA more than III, age less than 25 or more than 80, dementia, deafness, psychological disease, difficult to communicate, cannot lay flat, INR more than 1.7 or with significant coagulopathy

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

D50 Dexmedetomidine 50 micrograms group

D25 Dexmedetomidine 25 micrograms group

control

Arm Description

peribulbar block was given using 10 ml of a mixture of local anesthetics. The mixture was composed of 5 ml of 0.5% bupivacaine +4.5 ml of 2% lidocaine +0.5ml of 50 micrograms of Dexmedetomidine with 150 IU hyaluronidase.

peribulbar block was given using 10 ml of a mixture of local anesthetics. The mixture was composed of 5 ml of 0.5% bupivacaine + 4.5 ml of 2% lidocaine +0.5ml of 25 micrograms of Dexmedetomidine with 150 IU hyaluronidase.

peribulbar block was given using 10 ml of a mixture of local anesthetics without Dexmedetomidine. The mixture was composed of 5 ml of 0.5% bupivacaine +4.5 ml of 2% lidocaine +0.5ml with 150 IU hyaluronidase.

Outcomes

Primary Outcome Measures

IOP before the block, after the message and before the surgical incision, after the end of the surgery
IOP before the block, after the message and before the surgical incision, after the end of the surgery

Secondary Outcome Measures

Onset of the block
the time elapsed between the end of the block and the complete anaesthesia and complete or partial akainesia

Full Information

First Posted
July 20, 2016
Last Updated
July 26, 2016
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02846090
Brief Title
Dexmedetomidine as an Additive to Local Anaesthesia to Decrease Intraocular Pressure in Glaucoma Surgery
Official Title
Dexmedetomidine as an Additive to Local Anaesthesia to Decrease Intraocular Pressure in Glaucoma Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Nowadays, a number of cases with increased intraocular pressure and glaucoma have been shown a huge increase . This is because of the increase the geriatric population in the community and advanced medical care. Surgical correction, as a treatment, solves this problem greatly especially with the modern surgical techniques . Peribulbar block reduced the admission discharge time and reduced the burden on both the patients and the medical team. On the other hand, it carries the risk of increased intraocular pressure (IOP). Which, subsequently, limit its usage in glaucoma surgery. Dexmedetomidine, as an alpha 2 agonist, has a well-established role in decreasing intraocular pressure (IOP). This effect has been shown at a histological level and clinical level
Detailed Description
Nowadays, number of cases with increased intraocular pressure and glaucoma has been shown a huge increase . This is because of the increase the geriatric population in the community and advanced medical care. Surgical correction, as a treatment, solves this problem greatly especially with the modern surgical techniques . Peribulbar block reduced the admission discharge time and reduced the burden on both the patients and the medical team. On the other hand, it carries the risk of increased intraocular pressure (IOP). Which, subsequently, limit its usage in glaucoma surgery . Dexmedetomidine, as an alpha 2 agonist, has a well established role in decreasing intraocular pressure (IOP). This effect has been shown at a histological level and clinical level . It has been tested in many studies before as an additive to local anaesthetic to augment the effect of the block and to achieve an accepted level of patient sedation (**). Many routes have been tested such as intravenous infusion, intramuscular injection and topically with the local anaesthesia . There is a debate about the best route and the optimum dose that can achieve the desired clinical effect with the least side effects. There is no study, till now, has examined the effect of Dexmedetomidine in a diseased eye with pathology that leads to increased IOP. This study states the hypothesis that Dexmedetomidine locally as an additive to local anaesthesia in different doses, not only will increase the duration of the block or achieve some level of sedation, but also can reduce the IOP in this diseased eye to a level that will help the surgical conditions and improve the surgical outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D50 Dexmedetomidine 50 micrograms group
Arm Type
Experimental
Arm Description
peribulbar block was given using 10 ml of a mixture of local anesthetics. The mixture was composed of 5 ml of 0.5% bupivacaine +4.5 ml of 2% lidocaine +0.5ml of 50 micrograms of Dexmedetomidine with 150 IU hyaluronidase.
Arm Title
D25 Dexmedetomidine 25 micrograms group
Arm Type
Experimental
Arm Description
peribulbar block was given using 10 ml of a mixture of local anesthetics. The mixture was composed of 5 ml of 0.5% bupivacaine + 4.5 ml of 2% lidocaine +0.5ml of 25 micrograms of Dexmedetomidine with 150 IU hyaluronidase.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
peribulbar block was given using 10 ml of a mixture of local anesthetics without Dexmedetomidine. The mixture was composed of 5 ml of 0.5% bupivacaine +4.5 ml of 2% lidocaine +0.5ml with 150 IU hyaluronidase.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine to reduce the IOP
Other Intervention Name(s)
reduction of OCULAR HYPERTENSION
Intervention Description
Dexmedetomidine 50 micrograms group (D50) in which peribulbar block was given using 10 ml of a mixture of local anesthetics. The mixture was composed of 5 ml of 0.5% bupivacaine +4.5 ml of 2% lidocaine +0.5ml of 50 micrograms of Dexmedetomidine with 150 IU hyaluronidase.
Primary Outcome Measure Information:
Title
IOP before the block, after the message and before the surgical incision, after the end of the surgery
Description
IOP before the block, after the message and before the surgical incision, after the end of the surgery
Time Frame
one hour
Secondary Outcome Measure Information:
Title
Onset of the block
Description
the time elapsed between the end of the block and the complete anaesthesia and complete or partial akainesia
Time Frame
2 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patients who were ASA I-III, age more than 25 and less than 80 with diagnosed increased intraocular pressure and were legible for surgical correction Exclusion Criteria: Patients with known allergy to the medications to be given, ASA more than III, age less than 25 or more than 80, dementia, deafness, psychological disease, difficult to communicate, cannot lay flat, INR more than 1.7 or with significant coagulopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan Ali, lecturer
Phone
1001733687
Email
hassan364@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan Ali
Phone
1001733687
Email
hassan364@hotmail.com
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
1234
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dexmedetomidine as an Additive to Local Anaesthesia to Decrease Intraocular Pressure in Glaucoma Surgery

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