Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02495220

Collaborator

(none)

Enrollment

Location

Arms

28.1

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Postoperative Vomiting	Drug: SB dexmedetomidine bupivacaine block Drug: intravenous dexmedetomidine	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Nov 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics [4 hours postoperatively]
by analysis for number of infants withCRIES pain scale score >3
postoperative CRIES pain scale score [4 hours postoperatively]
(0-2 for each parameter)

Secondary Outcome Measures

vomiting scale score [4 hours postoperative]
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%). [intraoperative period]
by analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Univeristy Hospital	Assiut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

jehan ahmed sayed, assistant professor in anesthesia and intensive care department,faculty of medicine assiut university, Assiut University

ClinicalTrials.gov Identifier:

NCT02495220

Other Study ID Numbers:

IRB00008711068

First Posted:

Jul 13, 2015

Last Update Posted:

Jan 27, 2017

Last Verified:

Jan 1, 2017

Keywords provided by jehan ahmed sayed, assistant professor in anesthesia and intensive care department,faculty of medicine assiut university, Assiut University

Additional relevant MeSH terms:

Cataract

Pain, Postoperative

Vomiting

Postoperative Nausea and Vomiting

Dexmedetomidine

Bupivacaine

Study Results

No Results Posted as of Jan 27, 2017