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

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

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Dexmedetomidine to reduce the IOP

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.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 1234
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: D50 Dexmedetomidine 50 micrograms group; 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.	Drug: Dexmedetomidine to reduce the IOP; 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.; Other Names: reduction of OCULAR HYPERTENSION
EXPERIMENTAL: D25 Dexmedetomidine 25 micrograms group; 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.	Drug: Dexmedetomidine to reduce the IOP; 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.; Other Names: reduction of OCULAR HYPERTENSION
PLACEBO_COMPARATOR: control; 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.	Drug: Dexmedetomidine to reduce the IOP; 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.; Other Names: reduction of OCULAR HYPERTENSION

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of the block	the time elapsed between the end of the block and the complete anaesthesia and complete or partial akainesia	2 min

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ANTICIPATED): November 1, 2016
• Study Completion (ANTICIPATED): January 1, 2017

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (ESTIMATE): July 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Ocular Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 01001733687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED