Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Postoperative Vomiting
• Intervention / Treatment: Drug: SB dexmedetomidine bupivacaine block; Drug: intravenous dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut Univeristy Hospital
    • Sub-Investigator: Mohamed Amir F Riad, MD
    • Principal Investigator: jehan A Sayed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subtenon block Group (SB); received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture	Drug: SB dexmedetomidine bupivacaine block; SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
Experimental: intravenous dexmedetomidine Group(IV); received 1µ/kg IV dexmedetomidine after induction of anesthesia	Drug: intravenous dexmedetomidine; received 1µ/kg IV dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
vomiting scale score	a numeric rank score, where 0= no vomiting 1=vomited once and 2=vomited twice or more	4 hours postoperative
Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).	by analysis	intraoperative period

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: July 3, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: dexmedetomidine; postoperative pain; subtenon anesthesia; pov
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Lens Diseases; Nausea; Pain, Postoperative; Vomiting; Cataract; Postoperative Nausea and Vomiting; 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; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: IRB00008711068