Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery

NCT04668456 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 8/8/2020 ANET4
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Postoperative Pain

Keywords

subtenon; dexmedetomidine; cataract surgery

Outcome Measures

Primary Outcomes (1)

• duration of sensory block

  time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia

  24 hours

Secondary Outcomes (1)

• duration of motor block

  24 hours

Study Arms (3)

Group C (control group)

PLACEBO COMPARATOR

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%; Drug: bupivacine 0.5%; Drug: Normal saline

Group SD (subtenon dexmedetomiine)

ACTIVE COMPARATOR

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; Drug: lidocaine 2%; Drug: bupivacine 0.5%; Drug: Normal saline

Group ID (iv dexmedetomidine)

ACTIVE COMPARATOR

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; Drug: lidocaine 2%; Drug: bupivacine 0.5%

Interventions

Dexmedetomidine DRUG

the drug administered either subtenon ot iv

Group ID (iv dexmedetomidine); Group SD (subtenon dexmedetomiine)

lidocaine 2% DRUG

subtenon injection

Group C (control group); Group ID (iv dexmedetomidine); Group SD (subtenon dexmedetomiine)

bupivacine 0.5% DRUG

subtenon injection

Group C (control group); Group ID (iv dexmedetomidine); Group SD (subtenon dexmedetomiine)

Normal saline DRUG

either subtenon or iv

Group C (control group); Group SD (subtenon dexmedetomiine)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (3)

Ashraf magdy Eskandr

Shibīn al Kawm, Monufia Governorate, 1234, Egypt

Location

Osama A Elmorsy

Shibīn al Kawm, Monufia Governorate, 1234, Egypt

Location

Sadik A Sadik

Shibīn al Kawm, Monufia Governorate, 1234, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia, icu

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 16, 2020
• Study Start: August 15, 2020
• Primary Completion: March 14, 2021
• Study Completion: March 30, 2021
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)