Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

NCT02495220 | Unknown Phase 2 DMC

• 1 other identifier: IRB00008711068
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Postoperative Vomiting

Keywords

dexmedetomidine; subtenon anesthesia; postoperative pain; pov

Outcome Measures

Primary Outcomes (2)

• Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics

  by analysis for number of infants withCRIES pain scale score \>3

  4 hours postoperatively

• postoperative CRIES pain scale score

  (0-2 for each parameter)

  4 hours postoperatively

Secondary Outcomes (2)

• vomiting scale score

  4 hours postoperative

• Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).

  intraoperative period

Study Arms (2)

subtenon block Group (SB)

EXPERIMENTAL

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

Drug: SB dexmedetomidine bupivacaine block

intravenous dexmedetomidine Group(IV)

EXPERIMENTAL

received 1µ/kg IV dexmedetomidine after induction of anesthesia

Drug: intravenous dexmedetomidine

Interventions

SB dexmedetomidine bupivacaine block DRUG

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

subtenon block Group (SB)

intravenous dexmedetomidine DRUG

received 1µ/kg IV dexmedetomidine

intravenous dexmedetomidine Group(IV)

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status grade I and II infants (1-12month).
• undergoing elective cataract surgery in one eye under general anesthesia.

You may not qualify if:

• infection of the orbit,
• increased intraocular pressure(IOP),
• history of allergy to local anesthetics,
• history of previous eye surgery,
• cardiovascular or clotting disorders,
• full stomach,inner ear disorders or other conditions predisposing to vomiting
• airway abnormalities
• compromised sclera.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Univeristy Hospital

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Central Study Contacts

jehan A sayed, MD

CONTACT

+2 01006253939; jehan.alloul@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor in anesthesia and intensive care department,faculty of medicine assiut university

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 13, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

EG (1)