Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

NCT ID: NCT02495220

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-11-30

Brief Summary

The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.

Detailed Description

In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.

Conditions

Postoperative Pain; Postoperative Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

subtenon block Group (SB)

received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture

Group Type: EXPERIMENTAL

SB dexmedetomidine bupivacaine block

Intervention Type: DRUG

SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture

intravenous dexmedetomidine Group(IV)

received 1µ/kg IV dexmedetomidine after induction of anesthesia

Group Type: EXPERIMENTAL

intravenous dexmedetomidine

Intervention Type: DRUG

received 1µ/kg IV dexmedetomidine

Interventions

SB dexmedetomidine bupivacaine block

SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture

Intervention Type: DRUG

intravenous dexmedetomidine

received 1µ/kg IV dexmedetomidine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ASA physical status grade I and II infants (1-12month).

2. undergoing elective cataract surgery in one eye under general anesthesia.

Exclusion Criteria

1. infection of the orbit,

2. increased intraocular pressure(IOP),

3. history of allergy to local anesthetics,

4. history of previous eye surgery,

5. cardiovascular or clotting disorders,

6. full stomach,inner ear disorders or other conditions predisposing to vomiting

7. airway abnormalities

8. compromised sclera.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

jehan ahmed sayed

assistant professor in anesthesia and intensive care department,faculty of medicine assiut university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut Univeristy Hospital

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

jehan A sayed, MD

Role: CONTACT

jehan.alloul@yahoo.com

+2 01006253939

Facility Contacts

jehan A Sayed, MD

Role: primary

jehan.alloul@yahoo.com

+2 01006253939

MD

Role: backup

Other Identifiers

IRB00008711068

Identifier Type: -

Identifier Source: org_study_id