Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

Phase 2

• Conditions: Postoperative Pain; Postoperative Vomiting
• Interventions: Drug: intravenous dexmedetomidine; Drug: SB dexmedetomidine bupivacaine block

• Registration Number: NCT02495220
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-13
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous dexmedetomidine Group(IV)	intravenous dexmedetomidine	received 1µ/kg IV dexmedetomidine after induction of anesthesia
subtenon block Group (SB)	SB dexmedetomidine bupivacaine block	received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture

Primary Outcome Measures

Name	Time	Method
postoperative CRIES pain scale score	4 hours postoperatively	(0-2 for each parameter)
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assiut Univeristy Hospital; 🇪🇬 Assiut, Egypt