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Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

Primary Purpose

Postoperative Pain, Postoperative Vomiting

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
SB dexmedetomidine bupivacaine block
intravenous dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring dexmedetomidine, subtenon anesthesia, postoperative pain, pov

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut Univeristy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

subtenon block Group (SB)

intravenous dexmedetomidine Group(IV)

Arm Description

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

received 1µ/kg IV dexmedetomidine after induction of anesthesia

Outcomes

Primary Outcome Measures

Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics
by analysis for number of infants withCRIES pain scale score >3
postoperative CRIES pain scale score
(0-2 for each parameter)

Secondary Outcome Measures

vomiting scale score
a numeric rank score, where 0= no vomiting 1=vomited once and 2=vomited twice or more
Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).
by analysis

Full Information

First Posted
July 3, 2015
Last Updated
January 26, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02495220
Brief Title
Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery
Official Title
Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Vomiting
Keywords
dexmedetomidine, subtenon anesthesia, postoperative pain, pov

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subtenon block Group (SB)
Arm Type
Experimental
Arm Description
received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
Arm Title
intravenous dexmedetomidine Group(IV)
Arm Type
Experimental
Arm Description
received 1µ/kg IV dexmedetomidine after induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
SB dexmedetomidine bupivacaine block
Intervention Description
SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
Intervention Type
Drug
Intervention Name(s)
intravenous dexmedetomidine
Intervention Description
received 1µ/kg IV dexmedetomidine
Primary Outcome Measure Information:
Title
Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics
Description
by analysis for number of infants withCRIES pain scale score >3
Time Frame
4 hours postoperatively
Title
postoperative CRIES pain scale score
Description
(0-2 for each parameter)
Time Frame
4 hours postoperatively
Secondary Outcome Measure Information:
Title
vomiting scale score
Description
a numeric rank score, where 0= no vomiting 1=vomited once and 2=vomited twice or more
Time Frame
4 hours postoperative
Title
Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).
Description
by analysis
Time Frame
intraoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status grade I and II infants (1-12month). undergoing elective cataract surgery in one eye under general anesthesia. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jehan A sayed, MD
Phone
+2 01006253939
Email
jehan.alloul@yahoo.com
Facility Information:
Facility Name
Assiut Univeristy Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jehan A Sayed, MD
Phone
+2 01006253939
Email
jehan.alloul@yahoo.com
First Name & Middle Initial & Last Name & Degree
MD
First Name & Middle Initial & Last Name & Degree
Mohamed Amir F Riad, MD
First Name & Middle Initial & Last Name & Degree
jehan A Sayed, MD

12. IPD Sharing Statement

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Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

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