Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery

Sponsor

Menoufia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04668456

Collaborator

(none)

Enrollment

Locations

Arms

7.5

Anticipated Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Acute Postoperative Pain	Drug: Dexmedetomidine Drug: lidocaine 2% Drug: bupivacine 0.5% Drug: Normal saline	Phase 3

Detailed Description

Ophthalmological surgery can be performed under topical, regional or general anesthesia. Recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. Orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-Tenon's block.

The STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury.

Dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics.

Many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

75 Patients were assigned into three equal groups, all patients received 2.5 ml of local anesthetic mixture through subtenon block and IV infusion of drugs as follows: Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.75 Patients were assigned into three equal groups, all patients received 2.5 ml of local anesthetic mixture through subtenon block and IV infusion of drugs as follows: Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

The Effect of Subtenon and Intravenous Dexmedetomidine on Patients Undergoing Cataract Surgery: A Comparative Randomized Controlled Double Blind Study

Actual Study Start Date :

Aug 15, 2020

Anticipated Primary Completion Date :

Mar 14, 2021

Anticipated Study Completion Date :

Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group C (control group) Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.	Drug: lidocaine 2% subtenon injection Drug: bupivacine 0.5% subtenon injection Drug: Normal saline either subtenon or iv
Active Comparator: Group SD (subtenon dexmedetomiine) Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.	Drug: Dexmedetomidine the drug administered either subtenon ot iv Drug: lidocaine 2% subtenon injection Drug: bupivacine 0.5% subtenon injection Drug: Normal saline either subtenon or iv
Active Comparator: Group ID (iv dexmedetomidine) Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.	Drug: Dexmedetomidine the drug administered either subtenon ot iv Drug: lidocaine 2% subtenon injection Drug: bupivacine 0.5% subtenon injection

Arm

Intervention/Treatment

Placebo Comparator: Group C (control group)

Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.

Drug: lidocaine 2%

subtenon injection

Drug: bupivacine 0.5%

subtenon injection

Drug: Normal saline

either subtenon or iv

Active Comparator: Group SD (subtenon dexmedetomiine)

Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.

Drug: Dexmedetomidine

the drug administered either subtenon ot iv

Drug: lidocaine 2%

subtenon injection

Drug: bupivacine 0.5%

subtenon injection

Drug: Normal saline

either subtenon or iv

Active Comparator: Group ID (iv dexmedetomidine)

Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.

Drug: Dexmedetomidine

the drug administered either subtenon ot iv

Drug: lidocaine 2%

subtenon injection

Drug: bupivacine 0.5%

subtenon injection

Outcome Measures

Primary Outcome Measures

duration of sensory block [24 hours]
time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia

Secondary Outcome Measures

duration of motor block [24 hours]
time from injection of local anesthetic to complete recovery of motor function in all ocular muscles.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

ASA grade I-III
Aged 18-70 years
Both sex
Scheduled for elective phacoemulsification cataract surgery

Exclusion Criteria:

Coagulation abnormalities
Impaired mental status
Refusal of the patient
Uncontrolled glaucoma
Recent surgical procedure on the same eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ashraf magdy Eskandr	Shibīn Al Kawm	Menoufiya	Egypt	1234
2	Osama A Elmorsy	Shibīn Al Kawm	Menoufiya	Egypt	1234
3	Sadik A Sadik	Shibīn Al Kawm	Menoufiya	Egypt	1234